Test Method Validation Engineer

Job Title: Test Method Validation Engineer

Company: United Pharma Technologies

Location: Acton, MA Onsite, 5 Days per Week

Employment Type: Contract, 6 Months

Duration: 6 Months

Hours per Week: 40 Hours

Job Responsibilities

• Develop, review, and execute Test Method Validation (TMV) protocols in a Class III medical device manufacturing environment.
• Perform test method validation activities, including protocol development, execution, troubleshooting, and final report preparation.
• Conduct root cause investigations and support resolution of dimensional non-conformances.
• Support Non-Conformance Material Reports (NCMRs) and related quality investigations.
• Perform equipment validation and support measurement system-related technical assessments.
• Support engineering change orders, document change orders, and change-control activities.
• Review validation protocols, analyze results, and prepare technical reports.
• Collaborate with internal Quality, Engineering, and Manufacturing teams and external suppliers to resolve technical issues.
• Support site-to-site correlation studies and ensure consistency of measurement methods.
• Use Minitab to analyze validation data and support technical decision-making.
• Support calibration out-of-tolerance investigations and measurement system assessments, as needed.

Required Qualifications

• 5–8 years of relevant experience in metrology, test method validation, or medical device engineering.
• Bachelor's degree in Engineering or a related discipline.
• Experience working in a Class III medical device manufacturing environment.
• Strong hands-on experience in Test Method Validation (TMV), including protocol writing, execution, troubleshooting, and reporting.
• Experience with root cause analysis and dimensional non-conformance investigations.
• Knowledge of equipment validation, measurement systems, and change-control processes.
• Experience using Minitab for statistical analysis and validation data evaluation.
• Experience with engineering change orders and document change orders.
• Strong analytical, technical writing, troubleshooting, and problem-solving skills.
• Ability to work independently and collaborate effectively with Quality, Engineering, Manufacturing, and supplier teams.

Preferred Qualifications

• Experience with vision systems and optical measurement technologies.
• Experience supporting calibration out-of-tolerance investigations.
• Experience with measurement system correlation and dimensional inspection methods.

Pay Scale

• Anticipated hourly pay range: $45 - $50/Hr

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.