Product Engineer

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