Medical Device Senior Process Development Engineer

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.
• Vendor interaction experience.
• Laser welding experience is a plus.
• Any PLM and PLC logic experience is a plus.
• Proficient in Microsoft Word/Excel/Outlook

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