Design Assurance Engineer

1 day ago

Sacramento, California, United States Inspire Medical Systems Full time
About Inspire Medical Systems

At Inspire Medical Systems, we're revolutionizing the sleep industry with our innovative medical devices designed to improve the lives of those living with Obstructive Sleep Apnea (OSA). Our commitment to enhancing patient outcomes, acting with integrity, and leading with respect drives our mission to make a difference in the lives of our patients.

Why Work with Us

We value diversity, inclusivity, and collaboration. Our people-first culture offers hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off, and tuition reimbursement. If you're passionate about making a difference in people's lives and want to work with cutting-edge technology, join our team.

Job Summary

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

Key Responsibilities
  • Provide product expertise and guidance on global medical device standards or other specific industry standards to ensure compliance with those standards.
  • Ensure timely standards impact assessments and implementation of identified actions.
  • Partner with Development to generate project deliverables lists and conduct audits of deliverables prior to product release authorization.
  • Ensure design history content integrity, completeness, and regulatory/standards compliance.
  • Collaborate with cross-functional teams to resolve gaps and ensure quality objectives are met.
  • Support design assurance activities, including quality planning, design verification, design validation, and design transfer.
  • Partner with Development on the validation of test methods, including fixture, acceptance criteria, and test methodology development.
  • Support risk management activities from product concept through commercialization.
  • Provide quality engineering support for design changes, sustaining engineering projects, and supplier changes.
Requirements
  • Bachelor's degree in a technical or scientific field.
  • 3+ years of experience in a medical device quality or design assurance role for finished medical devices.
  • Comprehensive knowledge of medical device design standards and 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 and risk management tools such as dFMEA and pFMEA.
  • Knowledge of ISO and FDA/Quality System Requirements.
What We Offer

We offer a highly competitive benefits package, including multiple health insurance plan options, employer contributions to Health Savings Account, dental, vision, life, and disability benefits, 401k plan with employer match, identity protection, flexible time off, tuition reimbursement, and employee assistance program.

All employees have the opportunity to participate in the ownership and success of Inspire Medical Systems through equity awards and the Employee Stock Purchase Program.

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