Sr. Design Assurance Engineer

Job Description

Job Description

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.

Our focus on patient outcomes is at the core of everything we do, and our think I can attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

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!

ABOUT THIS POSITION

This position is responsible for quality assurance support of new product development projects and design changes. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects and will ensure that the quality objectives are met during the product development and design transfer life cycle.

This individual will also be responsible for assessing manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.

This position is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance and provide technical direction to Inspire staff on matters of quality and compliance throughout the product’s lifecycle.

This position will work with Development, Operations, Manufacturing, Material Quality and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Partners with Development to generate project deliverables list and conducts audits of the deliverables prior to product release authorization.
• Ensure design history content integrity, completeness, and regulatory / standards compliance; Collaboratively communicating & resolving gaps with cross-functional team members.
• Provide quality support for design assurance activities, including quality planning, design verification, design validation, and design transfer, including active cross-functional root-cause analysis investigation and resolution.
• Ensure appropriate statistical methods, including sample size determination are used for design testing.
• Partner with Development on the validation of test methods including fixture, acceptance criteria and test methodology development.
• Support and / or lead risk management activities from product concept through commercialization.
• Product expertise and guidance on global medical device standards or other specific industry standards to ensure compliance with those standards.

Lead and document standard updates and compliance reviews at the prescribed frequency.

• Provide quality engineering support for design changes, sustaining engineering projects and when applicable supplier changes.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Ensure quality system procedural requirements and development life cycle phases are followed.
• Support usability testing, biocompatibility testing and sterilization validation activities.
• Generate and / or approve the following : DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Design Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support both internal and external audit activities.
• Support other quality projects and initiatives as assigned.

Required Qualifications

• Bachelor’s degree in a technical or scientific field
• 6 - 10 years minimum experience a medical device quality or design assurance role for finished medical devices.
• Comprehensive knowledge on medical device design standards along with global regulations for medical device design.
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects
• Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.
• Experience with GHTF requirements for process validations, etc.
• Knowledge on ISO and FDA / Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
• Strong project and time management skills A Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint

Preferred Qualifications

• Experience with Class III active implantables
• Experience with sterilization validation per ISO 11135
• Experience in design reliability, process and product quality assurance functions
• ISO 13485 certified auditor or RAB auditor
• ASQ certifications; CRE, CQM, CQE, CQA etc.

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, 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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