Sr. Program Manager

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!

POSITION SUMMARY

Inspire Medical Systems is seeking an experienced and highly strategic Senior Program Manager to lead the cross-functional execution of next generation neurostimulator development programs through design verification & validation, FDA submission, regulatory approval, and commercial launch.

This role will serve as the central leader responsible for planning, coordinating, and driving the successful execution of one or more of the company's most critical product development initiatives. The Senior Program Manager will work across product development and the enterprise to create plans, ensure alignment, manage risks, and achieve key project milestones while optimizing resources and budgets across multiple concurrent projects.

The ideal candidate has extensive experience leading multiple, concurrent Class II or Class III medical device projects through design verification, design validation, regulatory submissions, and commercialization.

MAIN DUTIES/RESPONSIBILITIES

• Program Leadership
  • Lead new product design and integration work from design verification & validation through FDA approval and commercial launch.
  • Develop and maintain integrated project plans, schedules, critical path analyses, and resource forecasts.
  • Create and monitor program budgets in partnership with functional leaders, driving cost efficiencies and financial accountability.
  • Drive project governance, phase-gate reviews and project team decision making.
  • Partner with internal and external stakeholders to define and manage program scope and strategic priorities, ensuring cross-functional alignment around objectives, risks, timelines, and business outcomes.
  • Contribute to the growth and maturity of the PMO by standardizing program management best practices, tools, and templates.
  • Coach and mentor project team members and functional managers in program and risk management best practices.
  • Build and execute communication plans for project teams, key stakeholders, and executive leadership.

• Project Risk Management
  • Develop and maintain program risk management plans, risk logs, and escalation processes.
  • Identify, assess, and mitigate technical, clinical, regulatory and launch risks.
  • Lead cross-functional risk reviews and executive escalations.
  • Develop contingency plans for critical path activities.

• Product Development Execution
  • Coordinate execution of Design Verification activities.
  • Monitor completion of design inputs, outputs, verification protocols, test reports, and technical documentation to build the design history file.
  • Partner with engineering teams to ensure technical deliverables are completed on schedule.
  • Facilitate issue resolution across cross-functional teams.

• Regulatory & Quality Leadership
  • Coordinate preparation of FDA submission packages with Regulatory team.
  • Partner with Regulatory Affairs and Quality Assurance to ensure compliance with applicable standards and regulations such as:
    • FDA Design Controls
    • 21 CFR Part 820
    • ISO 13485
    • ISO 14971

• Launch Readiness
  • Coordinate launch planning activities across Marketing, Commercial, Clinical, and Customer Service.
  • Establish launch success metrics and readiness criteria.
  • Drive completion of all launch deliverables and executive launch approvals.
  • Monitor launch execution and post-market stabilization activities.

QUALIFICATIONS

· Bachelor's degree in Engineering, Science, Business, or related field.

• 10+ years of relevant project or program management experience.
• 4+ years leading complex medical device development projects.
• Demonstrated success leading products from development through regulatory approval and commercial launch.
• Proven ability to lead multiple concurrent projects and cross-functional teams without direct authority.
• Experience with FDA submissions for Class II and/or Class III medical devices.
• Strong communication, stakeholder engagement, and strategic planning skills, including presenting to executive leadership.
• Proficiency with program management tools (e.g., Microsoft Project, Smartsheet, AI).
• Strong understanding of:
  • Design Controls
  • Product Development Lifecycle
  • Design Verification and Validation
  • FDA regulatory processes
  • Quality Systems

• Implantable medical devices.
• Neurostimulation products.
• Electromechanical medical systems.
• A variety of program management methodologies, including Agile and Stage-Gate development models.
• PMO and portfolio governance environments.
• Led at least one major medical device program from proof of concept through pilot production and market introduction.
• Experience using generative AI for common tasks like meeting minutes, dashboarding, reporting, communications
• Experience managing budgets, timelines, and risks under contractual commitments with external development partners.
• PMP, PgMP, or equivalent program management certification.
• Master’s degree in Engineering, Science, Business, or related field.

#LI-Onsite

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

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 regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, 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 need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com

Inspire Medical Systems participates in E-Verify.