Director - Program Management

Director - Program Management

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 hybrid work schedules, 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!

ESSENTIAL JOB FUNCTIONS

We are recruiting for a Director, Program Management to join our team. In this role, you will lead the integration, planning and reporting of Inspire's contract manufacturers. This position involves cross-functional leadership and communication with operations, quality, product development and less frequently with other functions to manage contract manufacturing lines through qualification, ramp up and ongoing process improvement for production of Inspire products.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Conduct Operations Readiness Reviews and Quarterly Business Reviews with Senior Leadership
• 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
• Manage priorities across various products managed at several vendors
• Support product launches in partnership with Product Development, Quality, Regulatory, Operations, Marketing, Sales & Clinical Training including resources from both premarket and post market teams.
• Oversee internal and external design and test resources including work with contract manufacturers through all IQ/OQ/PQ/PPQ and design transfer activities
• 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, process 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

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

• Bachelor's degree in engineering or related field.
• 10+ Experience managing the process of designing, developing, and delivering innovative medical technology.
• Experience interfacing and communicating with cross functional stakeholders in coordination with contract manufacturers of finished medical devices
• Experience establishing and building highly effective premarket and post market teams consisting of internal resources, contract resources, and large external vendors.
• Experience managing timelines, budgets, and identifying critical path constraints
• Experience working with Agile principles
• Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
• Demonstrated Ability to Solve Problems
• Ability to travel up to 20%

Preferred:

• Master of Business Administration (MBA) or a Master's degree in engineering or related field
• Experience leading multiple active implantable medical product development and manufacturing qualification programs
• Experience leading cross functional communications 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
• Experience Building Plan Models using Monte Carlo Simulation
• Experience with Smartsheets or other Portfolio and Program Management (PPM) Platforms to plan programs, build dashboards and use as a program communication tool

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 anequal opportunityemployer 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.