Product Engineer in Danvers
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Job DescriptionJob Description
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, 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
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
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