Senior Quality EngineerMy client provides a first-of-its-kind cardiac therapy for heart failure patients who have exhausted other options. As their Senior Quality Engineer, you will own risk management and design quality across the full product development lifecycle for implantable electronic devices. The company is approaching a major product launch, and this role is central to getting there.Why you should applyFirst-of-its-kind cardiac therapy - your work directly enables a device that changes livesGenuine path to Quality Manager - the company is actively planning to hire post-launchCompetitive salary, plus annual bonus eligibility100% employer-paid medical, dental, and vision coverage for employee and family401(k) match up to 6%, plus paid vacation, floating holidays, sick time, and paid holidaysWhat you'll be doingOwn risk management end-to-end - authoring plans, facilitating assessments, and maintaining all risk documentation across the product lifecycleServe as the quality lead on product development teams, coordinating Design History Files and driving design control complianceReview and approve internal and external change orders, assessing risk impact on implantable device designsManage the post-market surveillance system, tracking complaint trends and linking findings back to the risk management frameworkSupport internal audits, CAPA ownership, and non-conformance investigations using formal quality engineering toolsAbout youBe able to do the job as described.Background with implantable or active electronic medical devicesHands-on experience with ISO 14971 risk management for product developmentFamiliarity with MDSAP and EU MDR in addition to 21 CFR Part 820Able to author and own design control documentation without guidance