Sr System Verification Engineer
Covidien - India

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Position reporting to the Principal Engineer System V & V.
  • The overall job of the Senior Engineer System V & V is one of creation and innovation, which leads to the development and introduction into production of new products/processes.
  • The Senior Engineer System V & V would be responsible for:
  • Planning, management, and oversight of system-level verification activities for complex medical devices (hardware and software)
  • Safety risk management per ISO 14971 and related risk-based standards
  • Verification of compliance to relevant standards (e.g. IEC 60601-1:2005 and collateral standards)
  • Planning and oversight relating to compliance of new and legacy products with international directives and standards (e.g. RoHS), functioning as a member of cross functional teams by providing technical expertise for projects or subprojects
  • Preparing time and cost estimates for projects
  • Providing strong technical contributions to product/process development projects.

  • Principal Accountabilities
    • Administers the safety risk management process for new product development.
    • Administers the system verification program for new product development.
    • Serve as a skill leader and facilitator for FMEAs and Fault Tree Analyses
    • Development of system-level verification plans and test procedures / protocols
    • Maintain traceability from requirements and design elements to corresponding verification activities
    • Coordinate system verification activities across functional areas
    • Works with functional management to determine strategies and development opportunities for department.
    • Develop requirements and specifications to support Design for Testability and Design for Reliability criteria
    • Participate in process improvement activities relating to product quality and new product development
    • Develop requirements and specifications for test systems required to support systems verification
    • Participate in cross-functional design reviews
    • Present verification strategies and test plans for cross-functional review
    • Provides technical leadership to teams of engineers and technicians in the pursuit of new technology.
    • Provides leadership, consulting and troubleshooting on technical problems that arise in product and process development.
    • Provides mentoring and developmental leadership to direct reports and team members in technical areas as well as DFSS and/or DMAIC Six Sigma tools.
    • Maintains appropriate communication channels with direct reports and team members.
    • Communicates resource or product performance issues to functional management in a timely manner.
    • Develops creative and innovative approaches to new processes and products.
    • Performs engineering measurements and analysis.
    • Records work in design history files.
    • Provides written reports, protocols, and personnel assessments as necessary.
    • Provides cost and activity accounting period reports as necessary.
    • Executes tactical implementation of strategic plans.
    • Assures compliance with company Standard Operating Procedures and policies.
    • Participates in team decision making.
    • Develops team problem solving and communication skills
    • Demonstrates skill in the use and care of all tools and equipment.
    • Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards.
    • Stays informed about applicable new rules, regulations, and standards.
    • Writes engineering test protocols for testing of component parts and integrated systems.
    • Prepares progress reports on projects as required.
    • Prepares oral presentations for various company meetings.
    • Develops and writes specifications for components/systems, product, processes, and packaging/labeling.
    • Maintains a clean, safe, and orderly work area.
    • Follows all safety procedures.

    Requirements

    EDUCATION:
    • Required:
    • Bachelor's degree in Electrical/ Electronics & Mechanical Engineering or related field.
    • Master's degree in a relevant engineering discipline, or related field.
    • Preferred
    • Green or Black belt Six Sigma Certification (DFSS or DMAIC)
    • Systems Engineering Certification (e.g. INCOSE ASEP/CSEP)
    • ASQ Certification CRE
    EXPERIENCE:
    • Required: Six (6) years experience in engineering practice.
    • Preferred:
    • Minimum Three (3) years experience with systems testing & verification in a medical device development environment (FDA 820 CFR, ISO 13485) or other regulated industry.
    • Participation in relevant technical societies

    Covidien - 10 months ago - save job - block
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    About this company
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    Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers...