The Electrical Engineer will be responsible for designing, implementing, and testing Inspire products including implantable and external devices. This position may include a variety of new product development and sustaining engineering opportunities.
- Lead new product development teams to commercialize new product and support business initiatives
- Provide system design, electrical and software expertise for new products as well as changes to existing products
- Lead product design reviews for products in development as well as continuation
- Lead and/or perform product verification, validation testing
- Lead and/or perform electrical verification and characterization testing
- Provide continuation engineering support for products as required
- Lead and/or support risk management activities in compliance with ISO 14971
- Assure compliance with industry applicable standards for medical devices, with a focus on Magnetic Resonance Imaging (MRI)
- 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 in the course of product development and market delivery
- Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations
- Develop, document, test, and maintain software for tools and test systems
- Lead transfer of designs to manufacturing, including process validation activities (IQ/OQ/PQ)
- Support new product launch planning in partnership with Marketing, Sales & Education
- Attend patient cases and support Inspire customers as required
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation, providing follow-up reporting as needed
- Complete training requirements and competency confirmations as required for this position within the required timeline
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement
Bachelor’s degree in electrical engineering or related field.
Master’s degree in electrical engineering or related field.
- Experience designing, developing, and delivering innovative medical technology
- Experience establishing and build highly effective product development teams consisting of internal resources, contract resources, and large vendors
- Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
- Active implantable medical product development experience
- Understanding of RF, analog, and digital design, including testing corresponding standards
- Understanding of software and firmware development, including testing and corresponding standards
- Understanding of Magnetic Resonance Imaging (MRI), including testing and corresponding standards
- Understanding of electrical safety testing and corresponding standards
- Extensive experience with manufacturing process validation activities (IQ/OQ/PQ)
- Extensive experience with industry standards for medical devices such as ISO/TS 10974, ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.