Medical Device Senior Process Development Engineer (Molding)

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Apetan Consulting, is seeking the following. Apply via Dice today!Position: Medical Device Senior Process Development Engineer (Molding)Location: Bloomington, IN (Hybrid)- LocalsDuration: 12+ month contractJOB 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 VietnamPreferred 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.