Product Engineer

Job Title: Product Engineer Location-Type: Danvers, MA- 3 days onsite Start Date Is: ASAP Duration: 6 Month Contract Compensation Range: $60-65/hr Benefits: Eligible for Health, Dental, Vision, 401K Role Overview We are seeking a high-energy, hands-on Product Engineer to join a fast-paced sustaining engineering team focused on the Automated Impella Console (AIC). This is a builder and driver role - someone who owns issues end to end, moves fast, and thrives in a multi-project environment with competing priorities. You will work alongside a close-knit team of systems and hardware engineers to triage field issues, support design changes, and sustain a life-critical medical device already in commercial release.

The ideal candidate brings a strong electrical engineering foundation, direct experience in regulated medical device environments, and a track record of driving CAPA and complaint investigations to closure. What You'll Do • Triage incoming system issues - field complaints, escalations, and CAPAs - and determine appropriate response level • Partner cross-functionally with EE, ME, Quality, Regulatory, and Manufacturing to investigate and resolve product issues • Drive root cause analysis and corrective action, from investigation through documentation and closure • Maintain and update quality system documentation - ECOs, risk files, and traceability matrices - inside a regulated QMS • Support verification and validation activities; not leading V&V;, but actively participating in testing protocols and rigor • Create concise summaries and decks for leadership updates on open issues and project status • Escalate appropriately and rapidly reprioritize in a dynamic, high-volume environment • Operate as a hands-on engineer - not just a coordinator - engaging directly with hardware and technical problems Required Qualifications • 3-5 years of electrical or electromechanical engineering experience in medical device • Direct experience with CAPA investigations, complaint handling, and hardware debugging • Demonstrated ability to work inside a regulated QMS environment with strong documentation discipline • Experience supporting a released, commercialized product in a sustaining or post-market engineering capacity • BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or equivalent • Comfortable managing multiple concurrent projects and shifting priorities without losing detail orientation Nice to Have • Exposure to cardiac, implantable, or life-sustaining device programs • Experience with console-based or capital equipment hardware systems • Systems engineering mindset - ability to connect hardware, software, and usability considerations • Familiarity with fast-moving medtech environments