Senior Product Development Engineer

Job Description

About the Role

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What You’ll Do

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• Take ownership of design changes from feasibility and prototyping through design verification (DV) and into manufacturing implementation.
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• Apply design controls, risk management, and structured engineering documentation practices throughout the product development lifecycle.
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• Develop and validate test methods, including simulated-use testing and IQ/OQ/PQ protocols, and see them through to execution.
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• Produce and maintain accurate drawings, specifications, and supporting engineering documentation.
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• Spend meaningful time on the manufacturing floor and in the lab, diagnosing and resolving product and process issues as they arise.
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• Act as the primary engineering liaison with client stakeholders, communicating project status, risks, and technical decisions clearly.
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• Set technical direction for an offshore engineering team, reviewing their analysis and guiding their work on your programs.
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Qualifications

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• 5–7+ years of hands-on experience in medical device engineering.
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• Experience with compliant balloon catheters, biopsy needles, or other catheter-based devices is a strong plus.
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• A track record of carrying design changes from concept through verification and into production.
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• Working fluency in design controls (DHF), risk management, and test method development and validation.
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• Familiarity with simulated-use testing and installation/operational/performance qualification (IQ/OQ/PQ).
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• Comfort producing and reading engineering drawings, specifications, and documentation to the standards of a regulated environment.
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• A self-starter mindset — someone who can take a problem on the floor and see it through without heavy oversight.
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Where You’ll Work

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This position is based onsite in Winston-Salem, NC. Expect regular time on the manufacturing floor and in the lab, along with frequent, direct interaction with client engineering stakeholders and the offshore engineering team you’ll be guiding.

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