Manufacturing Validation Engineer- Medical Device

Job Description

Job Description Role: Manufacturing validation engineer
Location: North Haven Connecticut

Duration: 18 months
Job duties:
Process and equipment qualification (IQ/OQ/PQ).
Development of test methods for Design VV, Process Validation, and Production
Validation of test methods
Execution of Engineering Builds, Gauge RR Studies, Attribute Analysis Studies, and other
validation work
Authoring/releasing

of new test methods and editing/redlining of old test methods

The

education/experience

I am looking for is as follows:
This position requires a Bachelor of Science in Engineering or combination of relevant education
and experience as well as 5 years relevant experience in medical device manufacturing.
Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
Clean room environment experience
Manufacturing Engineering and automation experience.
Experience with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and
statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Strong organizational skills, detail oriented.
Ability to collaborate within an organization across all functional departments (e.g. Legal,
Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
Questions to be asked to candidate (TA Team)
1. If having experience of validating Automated equipment? Assembly Equipment? In Manufacturing
2. If aware of Vision System?
3. If have Experience with Process and equipment qualification (IQ/OQ/PQ)?
4. If have experience of Development of test methods for Design VV, Process Validation, and
Production
5. Validation of test methods?
6. If have experience of Gauge RR Studies, Attribute Analysis Studies, sampling?

7. If having knowledge of medical device manufacturing and with strong working knowledge of
cGMPs?
8. If having experience of Test Method Validation and/or Measurement System Analysis?
9. Clean room environment experience

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