Senior Medical Device Process Development Engineer

Akkodis; Bloomington (IN); On-site; USD 150,000 - 180,000; Part time

Job summary

Akkodis is seeking a Medical Device Senior Process Development Engineer for a 12‑month contract in Bloomington, IN. You will design and optimize manufacturing processes for new medical devices, evaluating processing options based on technical and economic feasibility.

You will work with cross‑functional teams to implement cost‑effective systems and ensure compliance with FDA/ISO standards, helping bring devices from concept to production while upholding quality and schedule.

Qualifications

• Bachelor’s degree in Engineering is required.
• 5–7 years’ experience on a manufacturing line in a regulated environment (medical device/pharma/regulated industry).
• Strong knowledge of process validation, design for manufacturing, statistics and lean principles.
• Experience with ISO13485/FDA GMP and related standards.
• Experience with new equipment setup, qualification and validation.
• Laser welding experience is a plus.
• PLM and PLC logic experience is a plus.
• Proficient in Microsoft Word/Excel/Outlook.

Responsibilities

• Collaborate on design, development, and implementation of new manufacturing processes for new device designs.
• Execute methods for process development including DFA, process validation, process capability, lean manufacturing, equipment selection and specification development.
• Apply risk‑based approach during development, implementation and validation of all processes.
• Ensure Design for Manufacture and Lean principles are central to R&D and designs.
• Liaise with production engineering for layout plans and implementation of new processes and lines.
• Maintain process documentation (PFMEA, Production Instructions, Drawings).
• Collaborate with R&D, Operations, and Production to complete projects and objectives.
• Compare costs and benefits for in-house vs supplier options.
• Design and optimize processes and equipment for large and small scale manufacturing.
• Meet project timelines and performance expectations.
• Adhere to QMS and regulatory requirements (FDA 21 CFR 820, ISO 13485).

Skills

Process validation

Design for manufacturing

Lean manufacturing

Statistics

MS Word/Excel/Outlook

Education

Bachelor’s degree in Engineering

Tools

PLM

PLC logic

Job description

Akkodis is seeking a Medical Device Senior Process Development Engineer for a 12‑month contract in Bloomington, IN. You will design and optimize manufacturing processes for new medical devices, evaluating processing options based on technical and economic feasibility.

You will work with cross‑functional teams to implement cost‑effective systems and ensure compliance with FDA/ISO standards, helping bring devices from concept to production while upholding quality and schedule.