Inspire Medical Systems, a rapidly growing medical device company, is seeking an experienced Hardware Engineering Manager to join our Product Development team.

This position will focus on partnering with hardware technical leadership and program management to build and lead teams of engineers who are directly involved in product development efforts.

In this highly visible role, you will be working with with cross functional teams within product development and throughout the company to develop the next generation of Inspire products.

Who are we?

Inspire Medical Systems, located in Golden Valley, MN, 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.

Job Responsibilities

• Build and lead high-performing hardware development teams in developing high quality hardware, tests, and test systems.
• Support the development of new systems and the maintenance of existing systems
• Maintain consistent development methodologies, tools, and documentation across all projects and systems
• Lead continuous process improvement activities, including integration of custom and off-the-shelf tools
• Mentor and guide the career development of your teams
• Lead project management activities where appropriate, working with cross functional stakeholders to set priority and identify critical paths, risks, and dependencies
• 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
• Support new product launch planning in partnership with operations, marketing, sales & education

Required Qualifications

• 6+ years of product development experience
• 1+ year of building, managing, and leading high-performing product development teams
• Strong written and verbal communication skills with the ability to communicate with both internal and external stakeholders and senior leadership
• Bachelor's degree in electrical engineering or related field

Preferred Qualifications

• Master's degree in electrical engineering or related field
• Experience as technical leader of hardware development teams consisting of internal and contract resources
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development, and manufacturing
• Extensive experience with industry standards for medical devices such as IEC 62304, ISO 14971, etc.