Akkodis is seeking a Hybrid Medical Device Process Development Engineer for a six plus month contract opportunity with possible extension into 2025 with a client located 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 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.
Pay/Salary Range: $43.33 to $60.71 per hour depending on experience.
Hybrid Medical Device Process Development Engineer job responsibilities include: • Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Cook 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 work and interact effectively and professionally with and for others throughout various levels of the global organization. Must strictly adhere to safety requirements. Maintain regular and punctual attendance. Must maintain company quality and quantity standards. 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; or experience of such kind and amount as to provide a comparable background.
- 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 • One plus years experience minimum 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 Hybrid Medical Device Process Development Engineer job in Bloomington, IN then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/
The Company will consider qualified applicants with arrest and conviction records.