Medical Device Validation Engineer: Process & Test Methods

Pentangle Tech Services | P5 Group

North Haven (CT)

On-site

USD 90,000 - 120,000

Full time

2 days ago

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Job summary

Pentangle Tech Services | P5 Group is seeking a capable Manufacturing/Process Validation Engineer to lead IQ/OQ/PQ activities, develop test methods for V&V, and validate methods for medical-device production. The role requires strong cGMP knowledge and clean-room experience in a fast-paced environment.

Candidates should have a BS in Engineering with 5 years of relevant medical device manufacturing experience, plus proficiency in Excel and Minitab.

Qualifications

Bachelor of Science in Engineering or combination of relevant education and experience.
5 years relevant experience in medical device manufacturing.
Expertise in medical device manufacturing with strong working knowledge of cGMPs.
Clean room environment experience.
Experience with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of Excel and statistical packages (Minitab preferred).
Familiarity with FDA Quality System Regulation (21 CFR 820) and ISO 13485.

Responsibilities

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.