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