Medical Device Manufacturing Engineer (Cleaning Validation)

Akkodis is seeking a Medical Device Manufacturing Engineer (Cleaning Validation) for an 18-month job with a client in Warsaw, IN. You will be responsible for providing manufacturing cleaning validation engineering services. This position will support internal process validations with compliance to Code of Federal Regulations (CFR) section 820.75. This is an onsite position.

Rate Range: $40.00/hour to $45.00/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Medical Device Manufacturing Engineer (Cleaning Validation) job responsibilities include:

• Development, execution, and reporting of CFR 820.75 compliant process validations, specifically cleaning validations.

• Identification of key calibration requirements for equipment installation activities

• Equipment Installation Qualification for medical device production

• Equipment calibrations for medical device production

• Operational Qualification execution for medical devices

• Production Qualification execution for medical devices

• Statistical interpretation of attribute and variable results

• Prepare validation summary reports

Desired Qualifications:

• B.S. in mechanical, industrial, chemical engineering, or other engineering science, plus 1-2 years of manufacturing process development or validation experience in Medical device or pharmaceutical manufacturing.

• Skilled and knowledgeable in medical device manufacturing and product processing;

• Knowledge of drafting standards and geometric dimensioning and tolerancing

• Demonstrates ownership of and ability to manage project assignments with a broad scope and high level of complexity and able to prioritize and complete work in a timely manner.

• Demonstrates advanced problem solving skills through the use of quality and statistical tools

• Ability to effectively work within a team and cross functionally to expedite completion of critical project tasks.

• Knowledge of chemical vapor deposition processes is a plus

• Knowledge of medical device cleaning processes is required

• Demonstrates excellent written and verbal communication skills

• Microsoft Office Suite and Project; Statistical Process Control skills; proficient in process development, MINITAB statistical software, and Windchill PLM

• Knowledgeable in Good Manufacturing Practice and Good Documentation Practices

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