Contract Test Method Validation Lead – Med Device

Medical Engineering Consultants (MEC); Twin Lakes (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Medical Engineering Consultants (MEC) is seeking a Test Method Validation Engineer to lead TMV activities in a regulated manufacturing setting. You will plan, execute, and document TMV, and partner with Engineering, Quality, Manufacturing, Operations, and R&D to ensure methods meet quality, regulatory, and business requirements.

The ideal candidate has 5+ years of TMV experience in a medical device environment, strong technical writing skills, proficiency in Minitab, and a track record of

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years executing TMV activities.
• Experience in a regulated manufacturing environment; medical device preferred.
• Strong writing and documentation skills.

Responsibilities

• Lead and execute TMV activities with documented results.
• Develop and review validation plans, protocols, and reports.
• Plan validation testing, data collection, and analysis.
• Remediate historical validation records to meet current requirements.
• Collaborate with cross-functional teams on risk assessments and improvements.

Skills

TMV execution

Statistical analysis

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

Minitab

Job description

Medical Engineering Consultants (MEC) is seeking a Test Method Validation Engineer to lead TMV activities in a regulated manufacturing setting. You will plan, execute, and document TMV, and partner with Engineering, Quality, Manufacturing, Operations, and R&D to ensure methods meet quality, regulatory, and business requirements.

The ideal candidate has 5+ years of TMV experience in a medical device environment, strong technical writing skills, proficiency in Minitab, and a track record of