Remote- Senior Process Development Engineer
Location: Bloomington, IN (Hybrid)
Must have medical device or other regulated industry experience (automotive, aerospace, etc)
Job Description:
seeking a hybrid Medical Device Senior Process Development Engineer (Molding) for a 12+ month contract job with a client in Bloomington, IN. You will develop the processes required to manufacture medical devices designed by the R&D teams. Requires 3 days a week onsite.
Medical Device Senior Process Development Engineer (Molding) job responsibilities include:
• Collaborate in a team of engineers focused on design, development, and implementation of new processes required for the manufacture of new device designs.
• Manufacturing process heavy. Process development (DOE, master validation plan, process capability, equipment selection and specification) owner for processes associated with R&D projects. Oversee vendor process development/ validation/ transfer/ assembly processes at contract manufacturers.
• Ensure a risk-based approach is applied during development, implementation, and validation of all processes both within Company and with third-party suppliers.
• Ensure Design for Manufacture and Lean manufacturing principles are central to the R&D process and designs.
• Liaise with production engineering for process engineering layout plans and implementation.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.).
• Collaborate with R&D Teams to ensure effective completion of project activities.
• Build effective relationships with Operations, Quality, and Regulatory teams.
• Lead Make vs Buy decision and supplier selection.
• Support Regulatory Affairs with engineering input.
• Ensure effective transfer of new devices from Development to Sustaining cycles.
• Maintain company quality and quantity standards.
• Must have strong communication and leadership skills.
Desired Qualifications:
• Bachelor's degree in Engineering or related field.
• Minimum 10 years of experience in contract manufacturing, Class II/III medical device manufacturing (or other regulated industries), molding plastics (polypropylene and HDPE). Gamma Sterilization would be a plus.
• Ability to take conference calls with contractors in Vietnam
• Preferred Creo knowledge to collaborate with design to challenge vendor component designs, assembly processes (snapping, torquing caps, inserting lures) and vendor packaging/ sealing/ labeling.
• Experience completing projects within timelines.
• Strong analytical and problem‑solving skills.
• Preferred: Project management experience.
• Strong knowledge of ISO13485/FDA, GMP, validation, design for manufacturing, statistics, and lean principles.
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