Job Description

Very exciting opportunity with a small sized medical device company taking a product to market. We are looking for Manufacturing Process Engineering professionals to support this process.

Technical Expertise:

• Facilitate the transition of new or enhanced products from Engineering to Production.
• Responsibilities will encompass a thorough understanding of Bills of Materials (BOMs), design for manufacturability, process design, process validation, assembly techniques, and design evaluations.
• Skilled in drafting protocols and reports related to the development of new processes and the optimization/validation of existing ones.
• Capable of interpreting manufacturing instructions and standard operating procedures, as well as reading, analyzing, and creating engineering diagrams.
• Familiar with manufacturing techniques, including the fabrication of plastics and metals.
• Support the design, selection, and validation of new tools and equipment.
• Evaluate production workflows and metrics, including yield, capacity, and capability.
• Offer technical assistance to production and quality teams.
• Adept at solving problems using structured approaches and experienced in breaking down complex (e.g., device-level) performance challenges into actionable steps.
• Contribute to and/or lead risk assessment activities, such as process Failure Mode and Effects Analyses (FMEAs).
• Proficient in quality statistical models and metrics (confidence/reliability intervals, Design of Experiments (DOE), regression/trending, Statistical Process Control (SPC), t-Tests, acceptance criteria).
• Provide technical support to vendors and suppliers on related issues.
• Candidates must have at least 3 years of medical device manufacturing experience

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