Inspire Medical Systems, Inc. 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 be part of a purpose-driven company and directly help to transform lives, this is the perfect opportunity for you!
This position involves synthesizing customer needs, business needs, anatomical constraints, and technology expertise into product development and implementation plans for the next generation of Inspire products. This position will focus on implantable lead design and delivery tools as well as support continuation engineering as required.
- Technical lead on product development of implantable leads and delivery tools
- Lead product design reviews for products in development as well as continuation
- Support pre-clinical studies and consider anatomical constraints for product feasibility
- Create, control and store engineering drawings (CAD, SLDWKs, ProE, etc.)
- 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.
- Provide continuation engineering support for products as assigned
- 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
Bachelor’s degree in a mechanical engineering or related field.
Master’s degree in mechanical engineering or related field.
- Experience designing, developing, and delivering innovative medical technology (5+ years).
- Experience as technical contributor on product development teams consisting of internal resources, contract resources, and large vendors.
- Aptitude for understanding anatomy to drive product design
- Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email firstname.lastname@example.org.
Inspire Medical Systems participates in E-Verify.
- Extensive active implantable medical product development experience (10+ years)
- Experience as technical leader on product development teams consisting of internal resources, contract resources, and large vendors.
- Understanding of sterilization validation and the corresponding standards
- Understanding of biocompatibility material selection and testing
- 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.