Senior Product Development Engineer

Job Description

Where You'll Work

This position is based on-site 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.

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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What You Bring

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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
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• 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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