Biomedical Engineer/Validation Engineering

This is not an IT or Software position- these applicants will be disqualified.

Akkodis is hiring a Validation Engineer for a client in the Medical Device manufacturing industry. The position will operate onsite in Bloomington, IN.

The ideal candidate will have a Bachelors Degree in Mechanical or Biomedical Engineering and 3+ years of experience.

Summary

Review of process validations for identification of gaps to internal and external requirements. Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions This Engineering position will work within Pk48 Production Engineering - Process Validation

Department and with other functional groups, as needed, to identify process validation needs. Demonstrate the understanding of medical device regulations and best practices Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971). Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools

Pay Range: $50.00/hour to $55.00/ hour. The pay may be negotiable based on experience, education, geographic location, and other factors.

Contract: 12 months ( potential for extension)

The Validation Engineer performs and documents validations of medical device manufacturing processes.

Job Description:

Review of process validations for identification of gaps to internal and external requirements. Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions.

This Engineering position will work within Pk48 Production Engineering - Process Validation

Department and with other functional groups, as needed, to identify process validation needs.

Demonstrate the understanding of medical device regulations and best practices.

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

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

Open to US Citizens only

Requirements:

Biomedical Engineering Degree.

3+ years experience

Equal Opportunity Employer/Veterans/Disabled

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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