Manufacturing validation engineer

Job duties:

Process and equipment qualification (IQ/OQ/PQ).

Development of test methods for Design V&V, Process Validation, and Production

Validation of test methods

Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work

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

Education/experience:

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.