Product Development Engineer- Medical Device

This job is posted on behalf of Gallin Associates by Top Echelon.

Greater Fitchburg, MA area

CLIENT CANNOT SUPPORT ANY WORK VISA TRANSFER/SPONSORSHIP

Growing medical device manufacturer seeks a mid-level engineer to support high-volume custom device projects. You’ll own one or two validation projects at a time, writing protocols, coordinating execution with manufacturing, and driving projects through final approval. Work includes IQ/OQ/PQ, VV testing, PFMEAs and control plans, along with SolidWorks design support and engineering changes. Key interfaces include project stakeholders, suppliers, quality and production teams.

Requirements:

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• BS in Mechanical Engineering or related field
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• 3-5 years in a manufacturing environment
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• Hands-on product or process validation experience
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• Proficiency in SolidWorks and GDT
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• Medical device or plastics experience preferred
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