Onsite Medical Device Validation Engineer job in Bloomington, IN is available through Akkodis. You will work within Production Engineering - Process Validation Department and with other functional groups, as needed, to identify process validation needs. These are onsite contract opportunities with extension into 2025.

Rate Range: $55.00/hr; The rate may be negotiable based on experience, education, geographic location, and other factors.

Onsite Medical Device Validation Engineer job responsibilities include:

• Review of process validations for identification of gaps to internal and external requirements.

• Identify process validation needs

• Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures

• Meet and/ or beat designated deadlines

• Generate quality outputs for Design History File documents (generation of a PFMEA, etc.)

QUALIFICATIONS:

• Bachelor’s Degree in Mechanical, Biomedical or Chemical Engineering

• Requires two to four years of experience with packaging in medical device manufacturing.

• Demonstrate the understanding of medical device regulations and best practices

• Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools

• Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).

• MS Office proficiency. Excellent use of Microsoft Word, Excel. Minitab a plus

• Strong technical understanding of manufacturing, process development, and process validation

• Must work well with others, have good problem solving skills and have excellent communication skills (ability to summarize)

• Experience with Design History Files (DHF) and PFMEA’s

If you are interested in this role, 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, 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.

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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