Job Description

My 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 apply

• First-of-its-kind cardiac therapy - your work directly enables a device that changes lives
• Genuine path to Quality Manager - the company is actively planning to hire post-launch
• Competitive salary, plus annual bonus eligibility
• 100% employer-paid medical, dental, and vision coverage for employee and family
• 401(k) match up to 6%, plus paid vacation, floating holidays, sick time, and paid holidays

What you'll be doing

• Own risk management end-to-end - authoring plans, facilitating assessments, and maintaining all risk documentation across the product lifecycle
• Serve as the quality lead on product development teams, coordinating Design History Files and driving design control compliance
• Review and approve internal and external change orders, assessing risk impact on implantable device designs
• Manage the post-market surveillance system, tracking complaint trends and linking findings back to the risk management framework
• Support internal audits, CAPA ownership, and non-conformance investigations using formal quality engineering tools

About you

• Be able to do the job as described.
• Background with implantable or active electronic medical devices
• Hands-on experience with ISO 14971 risk management for product development
• Familiarity with MDSAP and EU MDR in addition to 21 CFR Part 820
• Able to author and own design control documentation without guidance