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: $55.00 hr.

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

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

The Company will consider qualified applicants with arrest and conviction records.

If you are interested in this entry level Validation Engineer position in Bloomington, IN then please click APPLY NOW.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

The Company will consider qualified applicants with arrest and conviction records.