Medical Device Senior Process Development Engineer (Molding)

Akkodis is 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.

Rate Range: $75.30/hour to $75.30/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

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 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.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance