Career

Immediate requirement of Supplier Quality Engineer in West Coast USA Immediate requirement of Mechanical Designers with Creo CAD Experience Immediate requirement for Plant Head at Delhi location Immediate requirement for Electrical Engineer at Seattle USA locationImmediate requirement for Procurement Manager at Delhi locationImmediate requirement for Asst. Sales Manager at Bangalore locationImmediate requirement for Mechanical Engineer at Seattle USA location

We are Hiring

We are looking for dedicated and creative professionals who are committed to contribute their innovation to business transformation. We always welcome talent with open arms. We provide them the right career path to grow and achieve their goal . We believe in innovative practice and promotion of new ideas which keep us to lead the IT industry. Our vision is to lead the IT industry and we are following our corporate philosphy i.e " Creativity Designs the Company ".

Sr. Design Quality Engineer
Job Responsibilities:
  • Being a part of core project team and lead the quality engineering across the entire development cycle.
  • Lead the development of CTQ’s, design input and output documents.
  • Lead the fixture qualification and test method validation.
  • Lead the development and implementation of design verification and validation plans with project design lead.
  • Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
  • Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements.
  • Responsible for co-leading stage gate reviews and signatory on all PDP document approvals
  • Manage electronic document control and version control on all project related documents.
  • Ensure adherence to the quality systems and design assurance SOPs
  • Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
  • Provide statistical testing and reliability plans.
  • Work closely with regulatory team to drive alignment of project documentation and regulatory requirements.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
  • Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
  • Co-Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
  • Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.
  • Participate in ISO13485 site certification for the facility.
  • What we're looking for in you:
    • Bachelors (or higher) degree in engineering with preference mechanical engineering.
    • 10+ years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance and documentation.
    • Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation.
    • Sound understanding of medical device regulatory requirements for Class II and III medical devices.
    • Project planning – resourcing, timelines, quality and budgets.
    • Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
    • Preference for candidates with CQE certification or similar training and experience
    • Proficient in project management tools like MS project.
    • Experience in GD&T
    • Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.
    Sr. Hardware Engineer (Electronics)
    Skills Set Required:
    • Experience of working with Microcontrollers (16bit & 32 bit), ARM Cortex
    • Well versed in designing Analog Circuits, Motor Control circuits, battery charging circuits
    • Deep Understanding of Brushed DC and BLDC motors & their control circuits / algorithms,
    • Exposure to Battery Chemistries (Li-Ion, Li-Poly, LiFePO4) and charging algorithms
    • Experienced in characterizing EMC / EMI performance, Thermal Performance, Efficiency of circuit elements / boards
    • Exposure to use of T&M equipment (MSO, Multimeters, Logic Analyzers, Thermal Test equipment)
    • CAD Tools (OrCAD, pSpice, LT Spice)
    Responsibilities:
    • Design & Develop microcontroller based circuits
    • Design & Develop Circuits for Motor Control, Battery Supervision & Charging, Analog circuits
    • Simulate & Test the circuits being designed
    • Work with SW engineering team on defining the HW / SW Interface
    • Test & Debug Hardware to resolve functional / performance issues
    • Work with Layout Engineer to release the PCB Layout and GERBER
    Qualifications and Experience
    • B.Tech in Electronics having 6+ years experience.
    Technician- Electronics
    Skills Set Required:
    • Proven experience in making electronic test zigs on general purpose boards, PCB rework including rework for fine pitch components.
    • High level of proficiency in soldering and de-soldering of components for fine pitch, power etc.
    • Ability to make test cables and knowledge about specialized tooling for same.
    • Ability to coordinate with different PCBA & PCB Fab houses for supporting in PCB  fabrication and ability to create assembly BOMs and coordination with procurement team to procure same.
    • Knowledge of IPC standards is a big plus.
    Qualifications and Experience
    • Bachelor/Diploma/ITI in Electronics having 4+ years experience in layout using Allegro tool.
    Recruitment Executive
    Position Overview:

    We are looking for an experienced person who has positive attitude, excellent English communication, comfortable with people skills and hard working. This position will own the sourcing of suitable profiles to fulfill engineering and IT positions.

    Roles & Responsibilities:
    • Screen, identify suitable candidates as per the guidelines.
    • Review candidate profiles and convert them into company format with best presentation
    • Interview candidates for HR and basic technical skills
    • Perform background checks on the candidates
    • Make candidate recommendations to the supervisor with proper reasoning
    Skills:
    • Excellent written and oral English communication
    • Good expertise on MS-office
    • Expertise to use of job hunting sites like, LinkdIn, Naukri etc.
    • Good decision maker skills and long term view of the personality
    • Experience on sourcing profiles for Engineering services skills like CAD, Design, Mechanical, Embedded, Software and Quality.
    Qualifications and Experience
    • 2+ years of experience in Recruitment for an IT and/or Engineering services company
    • B.A — English / BBA/MBA — HR, Sales and Marketing
    Embedded Designer
    Position Overview:

    We have a requirement of Embedded Designer role in R&D Engineering team

    Skills and Capabilities:
    • Ability to understand the requirements and embedded implementation of those requirements.
    • Experience in working with the Microcontroller/RTOS based embedded systems.
    • Ability to understand the requirements and design document to come out with test plan to perform unit level or system level testing.
    • Knowledge of embedded C and different development environments.
    • Experience in test automation using Python is big plus.
    Qualifications and Experience
    • 3+ years of experience in embedded design/test domain.
    • Diploma (Computer)/ MCA/ B.E./B.Tech. - Computers
    Industrial Designer
    Position Overview:

    We are looking for a Design Engineer (Alias, Solidworks, Rhinoceros) who's responsible for develop ideas for new products and the systems used to make them. They also modify existing products or processes to increase efficiency or improve performance using computer-aided design (CAD) software.

    Skills and Capabilities:
    • 4+ years of experience in working in Usability, UX, product development, establishing product best practices, performance validation testing and evaluation.
    • Ability to develop design concepts integrating technical and aesthetic considerations
    • Strong understanding of formal methods to assess and improve usability and error prevention mechanisms.
    • Test proof of concept prototypes with customers testing in simulated environments
    • Value engineering for the mechanical products in consumer industry.
    • Uses participatory design activities (e.g. paper prototype co-creation, card sorting) to understand vision, business model and assumptions and tacit knowledge about user needs and behaviors.
    • Conducts user research to understand user needs, mental models and working contexts
    • Synthesizes output of stakeholder research & creates visualizations that effectively summarize key insights related to user and customer needs and behaviors, product definition.
    Qualifications
    • B.Tech / M.Tech degree in Mechanical / Industrial Engineering.
    • Proficient at least in two of the following software: Alias, Solidworks, Rhinoceros
    Staff Engineer
    Position Overview:

    The Staff Engineer/ Senior Staff Engineer will be a member of the Engineering R&D team working on the development and support of the Trauma and Extremities ADAPT product. He/She will work closely with other members of the engineering staff to provide technical solutions to engineering problems. He/She will participate in the creation of design documentation, software code, test plans, and other project artifacts.

    Key Skills:

    Mandatory

    • Experience : 7 to 9 years
    • Clarity in object oriented concepts [OOPS / OOAD].
    • Good understanding of multithreading in both, design and implementation
    • Knowledge of Image processing, 3D Visualization, OpenGL, VTK, ITK
    • Experienced in C++ application development preferably with QT/QML framework
    • Good understanding of data structures.
    • Good understanding of Software Development Lifecycle (Use of software developments tools, such as compilers, interpreters, programming editors, debuggers, source code control, defect management)
    • Fast learner
    • Good communicator and Problem solving ability

    Good to have

    • Knowledge of Agile Scrum process or DevOps implementation
    • Medical devices development experiences
    • Experience with a documented software development processes or familiarity with FDA and ISO standards like IEC 62304

    SHORT-TERM SUCCESS METRICS (6-12 MONTHS)

    • Demonstrate strong programming skills
    • Demonstrate understanding of design and design patterns
    • Demonstrate strong knowledge on tools and technologies
    • Establish trusting relationship with the team and other stakeholders
    • Demonstrate problem solving capabilities.
    • Deliver on project commitments.

    LONG-TERM SUCCESS METRICS (1+ YEAR)

    • Learn and demonstrate Product and Domain understanding
    • Demonstrate solid understand of Software Development Lifecycle
    • Consistently deliver on Project commitments
    Qualifications and Experience
    • Bachelor degree in computer science or related field (such as computer engineering, software engineering, biomedical engineering, or mathematical sciences or electronics). Master’s degree is preferred. Combination of education and experience is acceptable.
    Senior Staff Engineer
    Position Overview:

    Senior Staff Engineer/Associate Principal Engineer will provide technical leadership to the ADAPT team.They help establish technical standards and drive overall technical architecture, engineering practices,and engineering methodologies. They work on our complex problems, building high quality, architecturally sound and accurate software for ADAPT product. The Staff Engineer will take lead in the implementation, and deployment of successful ADAPT software application software systems.Staff Engineers are pragmatic visionaries who can translate business needs as well as design philosophies into workable technology solutions.

    Key Responsibilities:
    • Fully and completely understand system interdependencies and limitations.
    • Lead implementation, and deployment of successful medical device systems. Aid the architect in design - Functionally decompose complex problems into simple, straight-forward solutions
    • Aid the architect in ensuring quality of design as well implementation. Lead technical code reviews.
    • Development of technical talent - Exert technical influence over team members, increasing their productivity and effectiveness by sharing deep knowledge and experience.

    SHORT-TERM SUCCESS METRICS (6-12 MONTHS)

    • Demonstrate strong technical (language) skills
    • Demonstrate good understanding of design and architecture
    • Demonstrate hands on experience on key tools and technologies
    • Establish trusting relationship with the team and other stakeholders
    • Demonstrate problem solving and technical mentoring capabilities.
    • Demonstrate solid understand of Software Development Lifecycle

    LONG-TERM SUCCESS METRICS (1+ YEAR)

    • Learn and demonstrate Product and Domain understanding
    • Learn and execute Medical Device product development using design control process
    • Learn and demonstrate proficiency in Orthopedics.
    Qualifications and Experience
    • Bachelor degree in Computer Science / Electrical or Electronic sciences / Communication or related field (such as software engineering, biomedical engineering, or mathematical sciences)from premier institutes with at least eight years of industry experience in professional software development. Master degree is preferred. Combination of education and experience is acceptable.
    • Required Basic Technical Competencies: Algorithms and data structures; Object oriented design and analysis; Expert in C++ programming concepts; development and verification methodologies; use of software developments tools, such as compilers, interpreters, programming editors, debuggers, source code control, defect management. Knowledge of Image processing, 3D Visualization, OpenGL, VTK, ITK.
    • Preferred Technical Competencies: Knowledge of QT/QML. Knowledge of Agile Scrum process or DevOps implementation is a plus. Medical devices development experiences a plus
    • Minimum of 8-12 years experience
    Supplier Quality Engineer
    Position Overview:

    Supplier Quality Engineers (SQEs) work with component suppliers, contract manufactures, and original equipment manufacturers, to ensure purchased components, sub-assemblies, and devices comply with all print specifications and applicable regulations. The goal of SQE is to work with suppliers to create a best in class, high performing, and optimal supply base. Implement effective supplier quality and development programs aimed at improving supplier quality systems, change management, enhancing capabilities, and ensuring long-term quality from our suppliers.

    Key Responsibilities:

    Responsibilities related to Supplier Performance Improvement:

    • Create and implement supplier improvement plans
    • Analyze supplier performance data and metrics (e.g. DPM, failure modes, trending, etc.)
    • Provide suppliers with comparative data and metric performance
    • Provide input to SDQE, Audit SQEs, and commodity team on supplier performance
    • Obtain process performance data from suppliers (e.g. SPC, FPY, fallout, etc.)
    • Present periodic Supplier Performance Review for area of responsibility

    Responsibilities related to Supplier Quality and Change Management:

    • Visit suppliers to resolve issues
    • Issue Supplier Corrective Action Requests and ensure suppliers implement robust corrective action which prevent recurrence (CAPA’s)
    • Ensure timely and accurate documentation of audit-ready non-conformance records
    • Execute Supplier Change Requests (SICR) related to manufacturing, process, or supplier requested changes
    • Complete component qualification via PPAP and Change Board deliverables (e.g. process validation, FAI, 100% layout, capability studies, write protocol, execute test, write report, etc.)
    • Develop, Establish and Implement DTS (Dock to Stock) process Improves quality and productivity Drives down inventory costs

    Responsibilities related to Continuous Improvement:

    • Identify areas of process and system improvement - Propose and implement changes
    • Drive and execute CTG (Cost to Transformation) initiative in bringing continuous improvement and reducing the cost.
    Skills & Capabilities
    • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
    • Working knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
    • Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
    • Strong analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
    • Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
    • Willing to travel in support of business needs to different geographical locations.
    • Working experience in medical device industry is preferred.
    • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
    • Lead Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements
    • ASQ CQE/CQM/PE certification
    Qualifications
    • Bachelor Degree in Engineering or Science fields
    • Minimum of 5-7 years experience in Quality / Engineering / Manufacturing environment.
    Senior Software Engineer
    Key Responsibilities:
    • Design and implement complex software components and subsystems including object-oriented analysis and design, drafting design documentation and planning and conducting integrations and component tests.
    • Highly skilled in C++, OOPS, Object oriented design and analysis, Multithreading (POSIX).
    • Expert level knowledge in Algorithms and data structures.
    • Atleast 4+ years’ experience in crating GUI applications using Qt, QML/QtQuick.
    • Very good exposure of using QT Creator IDE
    • Good knowledge of verification methodologies; Use of software developments tools, such as compilers, interpreters, programming editors, debuggers, source code control, defect management.
    • Good exposure in Test Processes and Software Testing methodologies.
    • Exposure to development of image processing applications.
    • Demonstrated knowledge of regulatory standards and quality processes.
    • Demonstrated communication and documentation skills.
    • Must be able and flexible to work well under changing priorities in a high energy and demanding environment.
    • Strong communication, analytical, and problem solving skills.
    • Goal oriented with strong sense of responsibility and team player.
    Desired Profile
    • Bachelor or Master Degree in Computer Science. Master’s degree is preferred.
    • 7+ Years
    • A software engineer must be able to work independently taking over high responsibility for his work.
    • Highly disciplined.
    • Excellent written/verbal communication.
    • Must be a team player to work in a collaborative environment
    Medical Quality Engineer — CAPA Management
    Position Overview:

    We are looking for a Medical Devices Quality Engineer having Experience in CAPA, complaint handling and good knowledge of Quality Management System per ISO 13485.

    Key Responsibilities:
    • Customer complaint handling
    • Should be able to document, review, evaluate and investigate responses on product complaints
    • Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions
    • Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
    • Collaborates with team members to do complaint investigations
    Qualification
    • Diploma/Bachelors in Mechanical Engineering.
    Skills & Capabilities:
    • Good analytical and problem-solving skills.
    • Knowledge of DFMEA/PFMEA/Control plan/7QC tools.
    • 3+ years of relevant work experience.
    • Proficient computer skills in Excel and Word
    • Experienced in 7 QC tools - Fish Bone Diagram, Pareto Charts, and Root Cause Analysis
    • 8D problem solving methodology.
    • Good understanding of database management of complaint records.
    • Prior experience using complaints processing software
    • Excellent documentation and communication skills.
    Supplier Quality Engineer — Medical Devices
    Position Overview:

    We are looking for a Supplier Quality Engineer to work closely with suppliers to ensure effective supplier management and responsible to collaborate across functional areas (R&D, Manufacturing,Procurement, etc.) to provide support for FMEA development, establishing Critical to Quality (CTQ)characteristics as well as communicate key characteristics of components to suppliers.

    Key Responsibilities:
    • Work with suppliers to initiate / review SCAR – Supplier Corrective Action Reporting
    • Work with suppliers to ensure all necessary quality activities are rigorously addressed during initial product release and change such as: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R, MSA, line release, ramp monitoring, etc.
    • Review and evaluate complaints for MDR reporting decisions in accordance with 21CFR 803 Medical Device Reporting and European requirements in accordance with MEDDEV 2.12/1
    • Coordinate with complaint handling team for project execution
    • Escalate any new, unknown risk or hazards for further evaluation and decisions.
    • Review and evaluate complaints with new or additional information to determine if the complaint requires MDR reporting and file MDRs as required.
    • Submit complaints requiring an MDR/FSCA to the FDA/EU - Competent Authority (CA) within 5 or 30 days as required per 21 CFR 803 / MEDDEV 2.12/1
    • Work with multidisciplinary and cross-functional teams from various business units to ensure the timely completion and closure of reportable complaints.
    Professional Requirements
    • Bachelor’s Degree in Engineering or equivalent combination of education and experience in medical device Industry
    • 5+ years’ experience in Quality / Engineering / Manufacturing environment.
    • Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
    • Willing to travel in support of business needs to different geographical locations.
    • Must have excellent data entry skills
    • Intermediate level ability to use most MS tools (Word, Excel, PowerPoint, etc.)
    Skills & Capabilities:
    • Strong working knowledge of quality assurance principles and practices like 8-D based Supplier Corrective Action request, industry and international safety standards
    • Excellent communication (verbal & written) skills and Practices analytical problem solving skills
    • Experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures.
    • Knowledge of the Purchasing function and associated commodity, supply base, quality and data management considerations. Understanding of Procurement, Supplier Relationship Management, Material and Supplier Quality and Data Management areas.
    • Working Knowledge of MEDDEV 2.12/1, FSCA, GMP, ISO 13485, EU MDR, 510(k)/PMA, 21 CFR Part 803 standards.
    Sr .NET Devloper
    Position Overview:

    Experienced and motivated professional who is talented to lead on the technical front, take challenges and work with globally distributed teams to develop cutting edge medical products.

    Key Responsibilities:
    • Requirement gathering, Designing, Implementation and Documentation
    • Leverage new technologies to excel product offering and performance
    • Mentor and train the team members technically to improve product quality
    • Work with all the stakeholders to ensure timely deliveries of the tasks
    • Compliance to Quality Management System and Design Controls
    Qualifications
    • B.Tech/B.E/M.C.A/M.Tech/MS. - Computers, Electronics/Telecommunications having 4+ year of Experience
    Skills & Capabilities:
    • 4+ years of Software Development experience with 3+ years of experience in WPF Applications
    • Solid hands-on experience in OOAD, OOPS concepts, C#, WPF, MVVM, Multi-threading, XML, with .Net Framework 4.0/4.5.
    • Strong hold on Architecture Designing, Design Patterns & UML
    • Good exposure in multi-tiered application development and databases.
    • knowledge of C/ C++/VC++, Win 32 API, COM.
    • Knowledge of GDI+, DirectX/DirectShow, WCF and XLINQ.
    • Experience in writing COM interoperability and wrapper applications in C# and C++.
    • Knowledge of third party tools like JIRA, Code collaborator, Nunit, NCover, CruiseControl, ANTS etc.
    • Excellent written and oral communication skills.
    • DICOM and HL7 knowledge
    • Experience in Image processing and Audio/Video processing applications
    • Experience in working with distributed teams across geographies
    • Experience in Agile Methodologies
    • Good understanding of SDLC process around new product development
    UI / Web Developer
    Position Overview:

    We are looking for candidate having experience in Web UI Design, MVC, SPA (Single Page Application), React/Angular, HTML5, CSS3, RESTful services, etc.

    Key Responsibilities:
    • Works in a Scrum team to design, develop and document features across subsystems.
    • Collaborates with System Engineers and peers to create detailed software designs.
    • Translates requirements into design and implementation of well-structured and documented software components.
    • Tests implemented features to ensure high quality.
    • Conducts/Participates in design reviews and code inspections.
    • Implements solutions to assigned defect issues.
    • Understands Robotics software platform and develops high quality software components to support Robotics
    Qualifications
    • B.Tech/M.Tech/MCA/BE Computer Science having 8+ years of Experience
    Skills & Capabilities:
    • Good knowledge of Object-Oriented Design and Implementation is required
    • Experience with C#, ASP.NET, JavaScript, jQuery, MVC, MS SQL, and Web API’s
    • Proficiency in React, Redux, AngularJS, HTML5, CSS3, jQuery, Bootstrap, ASP.NET, MVC, WebPACK
    • Knowledge and experience in GUI development with HTML5, JavaScript frameworks and CSS are added advantage
    • Knowledge of Data formats such as XML, JSON and databases MySQL/SQL Server, MongoDB, NoSQL etc.
    • Knowledge of Azure Web Apps (Azure Websites), Azure Web Jobs, Azure Storage Tables, Deploying Apps to Azure, Azure AD / AAD Sync are added advantage.
    • Knowledge of Agile Scrum process or DevOps implementation is a plus
    • Ability and interest to quickly learn and implement cloud technologies, micro services, Node.js, Data analytics tools and Machine Learning technologies
    Cloud Architect / Solution Developer
    Position Overview:

    We are looking for candidate having Experience in Python/C#/JavaScript/Node.Js, Microsoft Azure Cloud, Azure Storage, Azure SQL and other Azure PaaS services, Microservices, DevOps, Docker, Jenkins, Ansible etc.

    Key Responsibilities:
    • Works in a Scrum team to design, develop and document features across subsystems.
    • Collaborates with System Engineers and peers to create detailed software designs.
    • Translates requirements into design and implementation of well-structured and documented software components.
    • Tests implemented features to ensure high quality.
    • Conducts/Participates in design reviews and code inspections.
    • Implements solutions to assigned defect issues.
    • Understands Robotics software platform and develops high quality software components to support Robotics
    Qualifications
    • B.Tech/M.Tech/MCA/BE Computer Science having 8+ year of Experience
    Skills & Capabilities:
    • Strong understanding of current technology approaches, techniques and tools used for emerging trends, including IOT, SOA, and cloud “-as-a-service” offerings
    • Previous design and development experience with scalable cloud services (e.g., bing, SQL Azure, Azure, AWS, etc.)
    • Knowledge of Microservices, Design and development experience with distributed systems and operating systems
    • Good knowledge of Object-Oriented Design and Implementation is required
    • Knowledge of Azure Web Apps (Azure Websites), Azure Web Jobs, Azure Storage Tables, Deploying Apps to Azure, Azure AD / AAD Sync are added advantage.
    • Knowledge of Agile Scrum process or DevOps implementation is a plus
    • Ability and interest to quickly learn and implement Data analytics tools and Machine Learning technologies
    • Knowledge of Data formats such as XML, JSON and databases MySQL/SQL Server, MongoDB, NoSQL etc.
    • Experience with a documented software development processes or familiarity with FDA and ISO standards like IEC 62304 is a plus
    Quality Engineer
    Position Overview:

    .
    We are looking for candidate having Experience in Quality Management System

    Key Responsibilities:
    • Knowledge of Quality Management System requirements
    • Hands on Experience of handling Document and Record Control, Change Control
    • Managing Internal Audits
    • Exposure of NC/CAPA, Problem solving methodology
    • Supplier Assessments (Nice to have)
    Qualifications
    • Mechanical Engineer having 3+ year of Experience
    Skills & Capabilities:
    • Quality Management system
    • Good Communication Skills
    Supplier Quality Engineer@USA
    Position Overview:

    We are searching for passionate quality engineer to join our customer as they strengthen their product portfolio, expand our services and solutions, and bring game changing technology to market. This team member will be responsible for working collaboratively with a team of cross-functional engineers. We’re looking for the candidate to have the following qualities:

    • Curious, smart, and creative
    • Good judgment and decision making skills
    • Takes Ownership and Excellent communicator
    Key Responsibilities:
    • Responsible for auditing Supplier Controls processes, provide recommendations for continuous improvements and remediate open audit findings or observations.
    • Responsible to collaborate across functional areas (R&D, Manufacturing, Procurement, etc.) to provide support for FMEA development, establishing Critical to Quality (CTQ) characteristics as well as communicate key characteristics of components to suppliers.
    • Audit processes to ensure proper execution, CGMP and record creation
    • Interact in corporate systems to ensure appropriate supplier controls.
    • Develop recommendation to ensure compliance to 21 CFR 820 and ISO 13485
    • Communicate with suppliers to obtain necessary records where appropriate (FAI, Control Plans, CoC, etc.)
    • Confirm that processes affecting CTQs are in control
    Qualifications
    • BS or MS degree in Mechanical or Electrical Engineering with min 6 years in Medical Device Industry
    Required Background & Capabilities:
    • High level knowledge of the 21 CFR 820, ISO 13485 and ISO 14971, questioning attitude, able to prioritize and execute tasks in a dynamic environment.
    • Expert working knowledge of standards and regulations applicable to supplier controls affecting a medical device
    • Strong working knowledge of quality assurance principles and practices, industry and international safety standards
    • More than 5-years' experience in medical device or pharma environment
    • Excellent communication (verbal & written) skills and Practices analytical problem solving skills
    • Working knowledge of various software packages including Microsoft (Excel, Word, Project, and SharePoint) and SAP applications is desirable.
    • Knowledge of implementing testing frameworks
    • Highly organized with efficient use of time
    • Ability to facilitate collaboration with cross-functional groups development in a team environment
    Senior Sales Executive
    Position Overview:

    The position will be work independently to expand business and sales in the English-speaking nationals like USA, UK and Canada. The person will need to be very energetic and willing to work to achieve the aggressive sales targets.

    Key Responsibilities:
    • Build and maintain positive work relationships with clients to create a rapport that facilitates patronage and generates revenue
    • Develop and implement strategies effective for the extensive sales company products
    • Monitor the sales industry to identify changes in market trends and adjust accordingly
    • Apply understanding of market trends/business practices in taking decisions necessary for enhancing the sales process
    • Collect, analyze, and interpret sales records to obtain information useful in preparing reports
    Qualifications
    • Bachelors Degree in any discipline. Preferred: Masters degree in Business
    Required Background & Capabilities
    • 3+ year’s strong experience in a sales of online education software products.
    • Extensive knowledge of culture in the western countries and quick to adapt
    • Target oriented individual with a go-getter attitude towards achieving revenue targets
    • An effective communicator and quick decision maker keeping company policies and profitability in mind
    • Self-motivated and disciplined to ensure high productivity
    • Ability to attend online meeting with customer
    • Expertise to use Skype, online conference meetings and ability to close deals quickly
    • Strong Communication skills with strong business related knowledge
    • The ability and desire for sales job with a confident and determined approach
    • Highly self motivated and ambitious in achieving goals
    • Should possess the skill to work both in team and also perform independently
    Mechanical Design Engineer, Medical Devices
    Position Overview:

    We are looking for an energetic Creo 3.0 Design Engineer who has good english speaking skills, expert in GD&T and willing to go extra mile to achieve excellent in his/her work. He should be willing to work in the US time zone for few hours in the evening and is keen to learn things faster to deliver quality work.

    Job Responsibilities:
    • Mechanical designs for orthopedic, Spine productslike Pedicle screws, plates, access systems or related parts.
    • Analyzes engineering sketches, specifications, and related data and drawings to determine design factors such as size, shape, and arrangement of parts.
    • Sketches rough layouts and computes angles, weights, surface areas, dimensions, radii, clearances, tolerances, leverages, and location of holes.
    • Participate in the design of surgical instrumentation and implants.
    • 3D models and 2D print creation and dimensioning using Pro/E Creo.
    • Evaluate design changes, specifications for drawing release.
    • Work from company drawings, vendor drawings or specification.
    • Use corporate drawing standards and SOPs as guidelines.
    • Update existing drawings to current specifications.
    • Basic metrology skills to assist manufacturing with ensuring compliance with design specifications.
    • Continually promote the Vision and Corporate Vision of the company.
    Required Experience:
    • B.E / B.Tech or equivalent and minimum of three years of experience in Spine, Orthopedic products with overall 5 years of Design experience preferably In Creo.
    • USA H1B and / or B.V ready preferred
    • Open to travel to US immediately after joining and willing to work in USA long term as and when required
    • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
    • Ability to write routine reports and correspondence.Ability to speak effectively before groups of customers or employees of organization.
    • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
    • Proficiency with computer aided design modeling, preferably Pro/E Creo.
    • Excellent attention to detail and ability to multi-task.
    • Able to work with minimal supervision, both alone and in teams.
    • Must be a motivated individual that is able to work in a fast paced environment.
    • Good understanding and experience of applying of GD&T in drawings.
    Required Background & Capabilities
    • 3-6 years Medical Device packaging experience (sterile products)
    • Understanding of Manufacturing processes for sterile products
    • Understanding of protocols and validation procedures, as well as standards
    • Ability to modify existing packaging to develop a new packaging that will extend, Shelf life beyond their existing one which is one year.
    • Working knowledge of ISO 15223, 11607,ASTM F1980, ASTM F1886, ASTM D4169 and ASTM F88
    • Strong communication skills
    Packaging Design Engineer
    Position Overview:

    Manages packaging development and improvement projects to meet Company, and regulatory needs. Reviews and approves product engineering change orders and packaging process changes, including labels specifications and packaging related content. Consults with vendors in the development of packaging for components and materials.Establishes supplier quality standardsand supports supplier audits as needed.

    Key Responsibilities:
    • Maintains accurate and compliant documentation to meet Company and regulatory expectations.
    • Creates packaging related SOP’s and Work Instructions.
    • Translates requirements for ISO 11607-1:2006 for customers requiring packaging for terminally sterilized products to internal product development teams and packaging personnel supporting these operations.
    • Develops and executes test methods, validations, and protocols for packaging related developments and projects.
    • Designs product packaging for Siemens Medical products using ISO and ASTM guidelines for integrity and transportation robustness.
    • Justifies and prepares capital expenditures for new packaging processes and equipment.
    • Develops bar codes, symbology, and labeling processes when appropriate.
    • Fosters a high level of creativity and independence in the design and development of new or improved packaging processes, systems, prototypes and projects.
    • Works with key functions to design packaging through the use of appropriate structure analyses, test methods, design methodologies, feasibility justification, and business case processes.
    • Drives the interaction of key package, product, process and Supply Chain interfaces and incorporates them into packaging design.
    Qualifications
    • Bachelors Degree in Mechanical Engineering
    Required Background & Capabilities
    • 3-6 years Medical Device packaging experience (sterile products)
    • Understanding of Manufacturing processes for sterile products
    • Understanding of protocols and validation procedures, as well as standards
    • Ability to modify existing packaging to develop a new packaging that will extend, Shelf life beyond their existing one which is one year.
    • Working knowledge of ISO 15223, 11607,ASTM F1980, ASTM F1886, ASTM D4169 and ASTM F88
    • Strong communication skills

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