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Principal Systems Engineer

1 month ago

Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Job Title: Principal Systems Engineer

At Inspire Medical Systems, we are seeking a highly skilled Principal Systems Engineer to join our team in Minneapolis, MN. As a key member of our engineering team, you will be responsible for designing, developing, and delivering embedded software technology and mobile applications that meet the needs of our customers.

Key Responsibilities:

  • Lead new product development teams to commercialize new products and support business initiatives
  • Provide system design, software, and electrical expertise for new products as well as changes to existing products
  • Lead product design reviews for products in development as well as continuation
  • Provide continuation engineering support for products as assigned
  • Lead and/or support product-level risk management activities in compliance with ISO 14971
  • Assure compliance with industry-applicable standards for medical devices
  • Generate and approve design history file documents, device master record documents, and engineering change order records
  • Ensure all quality system, regulatory, legal, and business requirements are met during product development and market delivery
  • Support post-market (commercial) product and/or therapy-related investigations as well as CAPA activities and implementations
  • Work with contract manufacturers on process validation activities (IQ/OQ/PQ)
  • Support new product launch planning in partnership with Marketing, Sales & Education
  • Document product and therapy-related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
  • Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement

Requirements:

  • Bachelor's Degree in Software, Electrical Engineering, Biomedical, or a related discipline
  • 12+ years of engineering experience from a regulated industry (i.e., aerospace, healthcare, pharmaceuticals, etc.)
  • Demonstrated experience designing, developing, and delivering embedded software technology and/or mobile applications
  • Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership
  • Proficient with MS Suite (Word, Excel, Outlook)

Preferred Qualifications:

  • Advanced level degree in Software, Electrical Engineering, Biomedical, or related discipline
  • Experience with implantable medical product development
  • Previous software and/or firmware development experience, including Python, .NET, and/or CAD software
  • Agile software development experience
  • Demonstrated understanding of any or all of the following:
    • 21 CFR 820 requirements
    • IEC 62304
    • Electrical safety testing and the corresponding standards
    • ISO 13485 requirements for design, development, and manufacturing
    • ISO 14971
    • ISO 14708
    • EN 45502
    • ISO/IEC 60601
    • Manufacturing process validation activities (IQ/OQ/PQ)
  • Understanding of systems engineering best practices and how they apply to continuous process improvement usability standards and integration into the product development process