Senior Systems Engineer
1 week ago
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.
- 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).
- 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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