Product Development Engineer- Medical Device

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, V&V testing, PFMEAs and control plans, along with SolidWorks design support and engineering changes. Key interfaces include project stakeholders, suppliers, quality and production teams.

Requirements:

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