Principal Reliability Engineer

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

This position must provide expertise and leadership in the areas of product reliability and post market surveillance, including health hazard and risk assessments, root cause analysis, coding, product performance reporting, reliability monitoring and data analysis. This position will work with Development, Manufacturing, Regulatory, Product and Material Quality to ensure work is completed in accordance with Inspire procedures and geographic regulations. In addition, this role must be flexible for changing priorities and able to work without direct supervision.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Develop reliability models and conduct analysis of product performance.
• Manage and compile the Periodic Surveillance Update Report (PSUR)
• Develop and maintain Inspire complaint handling coding methods to facilitate performance monitoring and required external reporting such as IMDRF codes
• Lead and author health hazard evaluations/risk assessments by working cross functionally to ensure root causes and health impacts are properly documented and analyzed
• Manage and compile post market summary reports for geographies outside of the U.S. as needed to maintain regulatory approvals.
• Organize and lead post market risk management reviews with cross-functional teams to ensure risks are minimized and potential CAPAs are initiated.
• Lead/participate in system level risk management activities for compliance to ISO 14971 and update system level risk management documentation to assure post market surveillance data is integrated and compliant.
• Lead/participate in Adverse Event reviews with surgical training leadership.
• Support AI and post market regulatory submission responses to geographic regulators
• Participate in the product reporting process (complaint handling) as assigned for risk evaluation and safety review.
• Lead/support cross-functional teams to resolve quality issues and complete CAPAs.
• Support QMS audits with both internal and external auditors

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

• Bachelor's degree in a technical or scientific field, such as Statistics, Electrical, Mechanical, Materials or Biomedical Engineering.
• 12+ years minimum experience in quality, reliability or design function in the finished medical device industry
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects
• Experience with risk management tools such as dFMEA, pFMEA, FTA and HHE/HHA
• Experience with risk management standard ISO14971
• Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; FDA 21 CRF Part 820)
• Strong project and time management skills
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint

Preferred:

• Experience in process, material and product quality assurance functions
• Experience with Class III active implantables
• ASQ certifications; CRE, CQM, CQE, CQA etc.
• ISO 14971 training
• Experience with industry standards such as; IEC 60601, EN 45502, etc.

Physical Requirements:

• Ability to lift 30 lbs.
• Hepatitis B vaccination or willingness to be vaccinated

SALARY

The salary for this position is expected to be between ($141,400 - $212,200) and 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 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.