Senior Systems Engineer

1 week ago


Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
About the Role

We are seeking a highly skilled Senior Systems Engineer to join our team at Inspire Medical Systems I. As a key member of our product development team, you will play a critical role in designing, developing, and implementing next-generation medical devices.

Key Responsibilities:
  • Lead Product Development Teams: Collaborate with cross-functional teams to commercialize innovative medical devices and support business initiatives.
  • Provide Technical Expertise: Offer system design, software, and electrical expertise for new products and changes to existing products.
  • Lead Design Reviews: Conduct product design reviews for products in development and continuation.
  • Continuation Engineering Support: Provide continuation engineering support for products as assigned.
  • Product Risk Management: Lead and/or support product-level risk management activities in compliance with ISO 14971.
  • Compliance and Quality: Ensure compliance with industry-applicable standards for medical devices and quality system procedures/policies.
  • Documentation and Record-Keeping: Generate and approve design history file documents, device master record documents, and engineering change order records.
  • Post-Market Support: Support post-market product and/or therapy-related investigations, CAPA activities, and implementations.
  • Collaboration and Communication: Work with contract manufacturers on process validation activities (IQ/OQ/PQ) and support new product launch planning in partnership with Marketing, Sales & Education.
  • Field Reports and Investigations: Document product and therapy-related field reports within prescribed timelines and provide necessary documents for investigation.
Requirements:
  • Bachelor's Degree: In Software, Electrical Engineering, Biomedical, or a related discipline.
  • Experience: 6+ years of engineering experience from a regulated industry (aerospace, healthcare, pharmaceuticals, etc.).
  • Technical Skills: Demonstrated experience designing, developing, and delivering embedded software technology and/or mobile applications.
  • Communication Skills: Strong written and verbal communication skills with the ability to communicate with internal and external stakeholders and senior leadership.
  • Software Proficiency: Proficient with MS Suite (Word, Excel, Outlook).
Preferred Qualifications:
  • Advanced Degree: In Software, Electrical Engineering, Biomedical, or related discipline.
  • Medical Device Experience: Experience with implantable medical product development.
  • Software Development Experience: Previous software and/or firmware development experience, including Python,.NET, and/or CAD software.
  • Agile Development Experience: Agile software development experience.
  • Industry Knowledge: Demonstrated understanding of relevant industry standards and regulations.


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