Sewer

Key requirement - Design Verification is a MUST HAVE.

• Need candidates with strong, hands-on Design Verification (DV) experience
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• 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.

• 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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• Creo or Solid Works experience is preferred.
• Minitab experience is important.

• 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.