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!

POSITION SUMMARY

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 mechanical design as well as support continuation engineering as required.

MAIN DUTIES/RESPONSIBILITIES

• • Lead new product development teams to commercialize new product and support business initiatives
  • Provide mechanical design and material 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 engineering drawings (CAD, SLDWKs, ProE, etc.)
  • 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

QUALIFICATIONS

• Educational Requirements:
  • Required
    • Bachelor’s degree in a mechanical engineering or related field.
  • Preferred
    • Master’s degree in mechanical engineering or related field.
• Required Experience:
  • Experience designing, developing, and delivering innovative medical technology.
  • Experience establishing and building 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
• Preferred Experience:
  • Extensive active implantable medical product development experience
  • 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.

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 careers@inspiresleep.com.

Please click here to apply.