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Senior/Principal Design Assurance Engineer

San Francisco Metro Area, CA

Posted: 06/05/2019 Job Type: Engineering Job Number: JN -062019-25036

ROLE AND RESPONSIBILITIES:

  • Independently support new product development and design changes ensuring product quality, reliability, speed to market, reduction of risk to users, and regulatory compliance
  • Reviews and approves Verification and Validation methods including performance, biocompatibility, and manufacturing processes to ensure requirements are met
  • Assists in the determination of sample size, confidence levels, and associated statistics pertaining to Verification and Validation activities
  • Responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to customers or regulatory compliance
  • Assist the Design Assurance function to build a comprehensive Design Assurance system compliant to FDA requirements, by reviewing Design Control procedures and policies, and assisting in document writing
  • Provides assistance and mentorship to Engineering to implement an improved and robust Design Control system
  • Reviews product change notices and change documentation to ensure thorough review of quality documents submitted for technical changes, design changes or manufacturing changes in order to ensure all regulatory requirements related to these changes are completely followed and conform to the Design Control regulations
  • Application of Reliability requirements, Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, ICH Q9, IEC 60601 and ISO 14971 Risk Management

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

  • Minimum of 4 years of design control/testing experience in consumer electronics and/or electro-mechanical medical devices within an FDA QSR or ISO 13485 regulated environment
  • Star candidate possesses the following three traits:
    • Exceptional workplace collaboration and customer service
    • Possesses robust technical skills to facilitate critical, open and data driven thinking
    • Demonstrates an excellent attention to detail and respect for Quality and Regulations
  • Medical Device Experience is required
  • Experienced or educated in Electrical Engineering, Firmware Engineering, or Software Engineering

EDUCATION:

  • Bachelor s Degree in Engineering or similar technical field required at a minimum. Master s Degree preferred.
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