Job Description

About the Company - An R&D Process Development Engineer position in Bloomington, IN with an American manufacturer of medical devices is currently available courtesy of Akkodis Engineering.

This is not a software or IT related positon. NO C2C, vendors or referrals accepted.

Onsite: Bloomington, IN

Contract: 12 months (extension potential)

Pay Range: $46.00/hour to $50.00/hour. The pay may be negotiable based on experience, education, geographic location, and other factors.

About the Role - This position is 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. 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.

Responsibilities -

• Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Company Medical 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, test method validation, process validation, process capability, lean manufacturing, equipment selection and specification development).
• Utilize a risk-based approach is applied during the development implementation and validation of all processes.
• Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
• Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective.
• Compare costs and benefits when choosing product in-house or supplier selection.
• Define, identify, and procure new equipment for manufacturing processes.
• 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.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Must have effective communication skills, which may include oral or written.
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision. Ability to remain calm and receptive in fast paced situations.

Qualifications -

• PhD, MS, or Bachelor's degree in Engineering, or Engineering Technology, preferably Mechanincal Engineering.
• Experience in process development and creating process validation documents with knowledge in design for manufacturing, statistics and lean manufacturing principles.
• Experience in identifying process variation, process capability and evaluation and DOE's.
• Experience commissioning and qualification of new processes – equipment.
• 1-5 years professional experience working in medical device or automotive manufacturing or GMP regulated environment.
• Knowledge of process validation, equipment setup, design for manufacturing, statistics, manufacturing assembly design and lean manufacturing principles.
• Must have process/equipment validation and process characterization experience - IQ/PQ/OQ.
• Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards preferred.
• Experience using analytic skills and problem solving.
• Working knowledge of Microsoft Office Software (i.e. Word, Excel, Visio, Power point, MS Project).
• Preferred knowledge of 3D Modeling software, Creo or SolidWorks, and Minitab.

If you are interested in this Onsite R&D Process Development Engineer job in Bloomington, IN then please click APPLY NOW. For other opportunities available at Akkodis go to

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

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

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