Medical Device Senior 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 job with a client in Bloomington, IN. You will be responsible for the designing and optimizing of processes required to manufacture new medical devices. You will identify and evaluate innovative processing options based on product attributes for products, including evaluation based on technical and economic feasibility. You will also execute cost-effective systems in order to enhance the speed and quality of processing, and ensure produced items comply with government regulations and industry standards.

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 job responsibilities include:

• Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Company facilities and/or with third party suppliers) required for the manufacture of new device designs
• Execute methods needed for efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development)
• Ensure that a risk based approach is applied during the development implementation and validation of all processes
• Ensuring that the principles of Design for Manufacture, and Lean manufacturing are central to the R&D process and designs
• Liaise with production engineering for process engineering layout plans and implementation in relation to new processes and production lines
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products
• Collaborate with other R&D teams, Operations, and Production engineering to ensure the effective completion of all activities associated with an R&D Engineering project / objective
• Compare costs and benefits when choosing product in-house or supplier selection
• Design and optimize process and process equipment for large and small scale manufacturing
• Ability to complete projects within specific time lines and meeting performance expectations
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

Desired Qualifications:

• Bachelor’s degree in Engineering, or related field is required
• Minimum 5-7 years’ experience working on a manufacturing line in a Class II/III medical device, pharmaceutical, aviation/ aerospace, or automotive manufacturing environment.
• Strong knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
• Strong knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards
• Experience with new equipment set up, qualification and validation.
• Laser welding experience is a plus.
• Any PLM and PLC logic experience is a plus.
• Proficient in Microsoft Word/Excel/Outlook

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