Pr. Mechanical 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 involves synthesizing customer needs, business needs, and technology expertise into a system design and product development and implementation plans for the next generation of Inspire products. This position will focus on physical components of the Inspire System regarding internal design/development, design transfer, and support continuation engineering efforts as required.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

1. Provide technical leadership related to product design including tasks such as establishing requirements, managing vendors, achieving project deliverables & timeline
2. Provide mechanical design and material expertise with a focus on implantable devices
3. Clearly communicate key technical updates to stakeholders
4. Lead the design & execution of structured experimental plans to drive data-based decisions via characterization, verification, and validation testing.
5. Solve engineering problems by analyzing the situation and recommending solutions or alternative actions
6. Lead product technical reviews and design reviews for products in development as well as post market products
7. Support or lead post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations
8. Create/Demonstrate a strong team culture around high expectations & performance
9. Create, control and store engineering parts and drawings within CAD Software database
10. Lead and/or support product level risk management activities in compliance with ISO 14971
11. Serve as mechanical engineering liaison to cross-functional partners to ensure project success
12. Generate and approve design history file documents, device master record documents, engineering change order records, and other quality systemdocuments and records
13. Provide continuation engineering support for products including review of supplier change requests, non-conforming reports and temporary deviations
14. Work with contract manufacturers on process validation activities (IQ/OQ/PQ)
15. Support patient cases and Inspire customers
16. Develop, disclose, and support the patenting of innovative technology and solutions

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

1. Minimum 10 years of experience in product development
2. Experience designing, developing, and delivering innovative medical technology
3. Experience with mechanical and electrical testing including verification and validation activities
4. Experience completing and documenting root cause analysis for products and/or processes
   1. Experience as technical leader on product development teams consisting of internal resources, contract resources, and large vendors
   2. Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing
   3. Bachelor's degree in mechanical engineering or related field

Preferred:

1. Active implantable medical product development experience
2. Experience with manufacturing process validation activities (IQ/OQ/PQ)
3. Experience leading, completing, and documenting CAPA activities
4. Understanding of biocompatible material selection and testing
5. Understanding of sterilization validation and the corresponding standards
6. Experience with industry standards for medical devices such as ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.
7. Master's degree in mechanical engineering or related field

SALARY

The salary for this position is expected to be between $153,000 - $190,000 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.