Medical Device Senior Process Development Engineer (Molding)

Position: Medical Device Senior Process Development Engineer (Molding)

Location: Bloomington, IN (Hybrid)- Locals

Duration: 12 month contract

JOB DESCRIPTION:

Must have medical device or other regulated industry experience (automotive, aerospace, etc.)

Job Description:

You will develop the processes required to manufacture medical devices designed by the R&D teams.

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.