Job Description
Key requirement – Design Verification is a MUST HAVE.
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- Need candidates with strong, hands-on Design Verification (DV) experience.
- Candidates must understand the full DV lifecycle – planning/organizing testing, writing protocols, executing tests, troubleshooting issues, analyzing data, and preparing technical reports/justifications.
- During the recruiter screen, ask candidates to walk through one actual DV project from start to finish. Do not rely only on the “Design Verification” keyword on the resume.
- Strong technical writing is very important.
- Minitab is important because the team uses it for data/statistical analysis.
- Hands-on testing/lab experience and experience directing or coordinating technicians are valuable.
- Strong communication, teamwork, cross-functional collaboration, and time-management skills are required.
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Medical Device / Industry Background
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- Medical-device experience is highly preferred, but candidates from other regulated/device industries can be considered.
- Experience with other medical devices is acceptable; they do NOT need experience with the exact same device.
- Catheter construction experience is NOT mandatory. Do not reject a strong DV candidate simply because they lack catheter experience.
- Manufacturing knowledge is important. Product transfer experience is only moderately important; they need to understand manufacturing processes rather than necessarily having performed product transfers.
- Manufacturing Engineers can be considered if they have strong DV/testing experience.
- Pure manufacturing candidates without meaningful DV/testing experience are not a fit.
- Product design experience is less important than the ability to plan, execute, analyze, and document testing.
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Tools
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- Creo or SolidWorks experience is preferred.
- Minitab experience is important.
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Experience
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- BS + 5 years OR MS + 4 years is the target.
- Manager confirmed 4 years with a Bachelor's can be considered if the experience is highly relevant.
- No strict upper experience limit; candidates with 12–15+ years can also be considered.
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