Location: Osseo, MN
Salary: $40.00 USD Hourly - $50.00 USD Hourly
Description: Job Title:Test Method Validation (TMV) Engineer / Specialist
Location:Onsite - 5 days per week (Monday-Friday)
Standard hours: 8:00 AM - 5:00 PM
(Some flexibility for unique circumstances) Summary:A leading medical device organization is seeking experienced
Test Method Validation (TMV) Engineers/Specialists to support a
short-term, high-priority project tied directly to an upcoming commercial launch.
This role is focused on
process characterization and test method validation activities for a single program with aggressive timelines. The consultant will play a hands-on role in drafting protocols, executing validation activities, and authoring reports in a highly collaborative onsite environment.
Required / Mandatory Skills:- Strong hands-on experience with Test Method Validation (TMV), including:
- Attribute methods
- Variable methods
- Destructive methods
- Ability to independently:
- Draft TMV and process characterization protocols
- Execute validation testing and collect data
- Analyze results and author clear, compliant validation reports
- Experience training operators or technicians on test methods
- Working knowledge of process characterization
- Ability to work onsite full-time and collaborate closely with cross-functional teams
- Comfortable working in a fast-paced, deadline-driven environment
Qualification:- 3-5 years of relevant Test Method Validation experience in a regulated environment (medical device preferred)
- Proven experience supporting validation activities from protocol through final report
- Ability to work independently with minimal supervision
Nice to Have (Not Mandatory):- Experience with catheter manufacturing processes
- Prior involvement in medical device development or commercialization projects
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