Inspire Medical Systems 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 become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!

Position Summary:

This position involves leading program management of Inspire's next generation of products. This involves cross functional communication with quality, operations, marketing, and sales, as well as leading product development teams of internal and external resources.

MAIN DUTIES/RESPONSIBILITIES:

• Lead cross-functional technical teams to develop and commercialize new products that support business initiatives
• Lead communication with cross functional stakeholders to review project status and resource needs
• Support product launches in partnership with Operations, Marketing, Sales & Clinical Training
• Oversee internal and external design resources including work with contract manufacturers
• Develop and manage policies, process and procedures that affect program management
• Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
• 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
• Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations.
• Attend patient cases and support Inspire customers as assigned

Required Qualifications:

• Bachelor's degree in engineering or related field.

• Experience managing the process of designing, developing, and delivering innovative medical technology.
• Experience interfacing and communicating with cross functional stakeholders
• Experience establishing and building highly effective product development teams consisting of internal resources, contract resources, and large external vendors.
• Experience managing timelines, budgets, and identifying critical path constraints
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing

Preferred Qualifications:

• Master of Business Administration (MBA) or a Master's degree in engineering or related field

• Experience leading multiple active implantable medical product development programs
• Experience leading cross functional communication and resource planning
• Extensive experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
• PMP Certification
  

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 dot com.

Inspire Medical Systems participates in E-Verify.