This position involves synthesizing customer needs, business needs, and technology expertise into a system design and product development and implementation plans for the next generation of Inspire products. This position will also provide functional technical leadership for therapy and product system design as well as support continuation engineering as required.
- 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
- 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 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.
- Create, control and store software source and executable code.
- Work with contract manufacturers on 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 assigned
- 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.
- 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 software or electrical engineering or related field.
Master’s degree in software or 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
- Minimum of 5 years of engineering experience, preferably in a regulated industry
- Extensive active implantable medical product development experience
- Understanding of electrical safety testing and the corresponding standards
- Understanding of software and/or firmware development, testing and the corresponding standards
- Understanding of usability standards and integration of them into the product development process
- Extensive experience with manufacturing process validation activities (IQ/OQ/PQ)
- Extensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc