Medical Device Process Development Engineer – Cleaning Validation

Akkodis is seeking a Medical Device Process Development Engineer – Cleaning Validation for a 12-month contract job with a client in Bloomington, IN. You will be responsible for the designing and optimizing of cleaning 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.

Rate Range: $40.00/hour to $46.43/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device Process Development Engineer – Cleaning Validation 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, 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 (PFMEAs, 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.

Desired Qualifications:

• PhD, MS, or Bachelor's degree in Engineering, or Engineering Technology

• Minimum of three years’ experience working in Class II/III medical device manufacturing or GMP regulated environment with cleaning validation.

• Experience in 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

• Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles.

• Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards.

• 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, Solid Works, etc.)

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