Onsite Medical Device Validation Engineer

An 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. This is an onsite contract opportunity through 2024, with possible extension into 2025.

The salary for this position is between $38.68 per hour. This position offers an allotment of up to $80.00/day for housing (up to $1500/month) and a possible $76.00/day on-site allotment for those who qualify!

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 one year of experience 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 Onsite Medical Device Validation 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.