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Senior Electrical 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 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

The Senior Electrical Engineer will be responsible for designing, implementing, and testing Inspire products including implantable and external devices. This position may include a variety of new product development and sustaining engineering opportunities.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

Lead new product development teams to commercialize new product and support business initiatives
Provide system design, electrical and software expertise for new products as well as changes to existing products
Lead product design reviews for products in development as well as continuation
Lead product verification and validation testing
Lead electrical verification and characterization testing
Provide continuation engineering support for products as required
Lead and/or support risk management activities in compliance with ISO 14971
Assure compliance with industry applicable standards for medical devices, including Magnetic Resonance Imaging (MRI)
Generate and approve design history file documents, device master record documents and engineering change order records
Ensure all quality system, regulatory, legal, and business requirements are met in the course of product development and market delivery
Support post market (commercial) product and/or therapy related investigations as well as CAPA activities and implementations
Lead development, documentation, test, and maintenance of software for tools and test systems
Lead transfer of designs to manufacturing, including process validation activities (IQ/OQ/PQ)
Support new product launch planning in partnership with Marketing, Sales & Education
Support Inspire customers as required

QUALITY SYSTEM RESPONSIBILITIES

Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
Complete training requirements and competency confirmations as required for this position within the required timeline.
Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

What You'll Bring

Educational Requirements:

Bachelor's degree in electrical engineering or related field.
Master's degree in electrical engineering or related field preferred.

Required Experience:

Minimum of 7 years of experience in an electrical engineering capacity
Experience designing, developing, and delivering innovative medical technology
Experience establishing and build highly effective product development teams consisting of internal resources, contract resources, and large vendors
Understanding of 21 CFR 820 requirements as well as ISO 13485 requirements for design, development and manufacturing

Preferred Experience:

Active implantable medical product development experience
Understanding of RF, analog, and digital design, including testing corresponding standards
Understanding of software and firmware development, including testing and corresponding standards
Understanding of Magnetic Resonance Imaging (MRI), including testing and corresponding standards
Understanding of electrical safety testing and corresponding standards
Extensive experience with manufacturing process validation activities (IQ/OQ/PQ)
Extensive experience with industry standards for medical devices such as ISO/TS 10974, ISO 14971, ISO 14708, EN 45502, ISO/IEC 60601, etc.

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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.

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