Principal Systems Engineer – Minneapolis, MN
Inspire Medical Systems has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient’s outcome is first and foremost our top priority. If you want to become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!
Position Summary:
We are recruiting for a Principal Systems Engineer to join our team located in the Minneapolis, MN location. In this role, you will be synthesizing customer needs, business needs, and technology expertise into a system design, product development and implementation plans for the next generation of Inspire products. You will also provide functional technical leadership for therapy and product system design as well as support continuation engineering as required.
Responsibilities:
- Lead new product development teams to commercialize new product 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
Required Qualifications:
- 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