TMV Engineers

Job 2509 Equipment Qualification (TMV) - Contract located near Albany, NY

The role partners with internal manufacturing & quality engineering teams to remediate existing manufacturing processes. The engineer owns process & test method validation – qualifying equipment, executing IQ/OQ/PQ and TMVs to ensure compliance to internal and external regulatory and procedural requirements. The engineer is responsible for working across cross-functional teams in order to meet defined project timelines.

• Develop and execute IQ, OQ, and PQ protocols for equipment, utilities, processes, and software used in medical device manufacturing
• Develop validation protocols for test methods that adequately challenge product design and related processes
• Author and review validation plans, reports, and supporting documentation
• Collaborate with engineering, manufacturing, and quality teams to ensure timely and compliant validation activities
• Perform gap assessments and redline SOPs, MIs, and QCs to align with processes
• Verify that all welded components meet design specifications, safety standards, and validation requirements
• Collaborate with engineering and quality teams to document welding processes and ensure traceability within validation protocols

• Strong Emotional Intelligence, situational leadership, and ability to manage by influence.
• Results‑oriented, positive attitude focused on delivering timely, accurate and best in class execution.
• Comfortable communicating to and presenting in front of all levels of the organization.
• Proficiency in MS Office applications

Equal Employment Opportunity:
Medical Engineering Consultants (MEC) is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, gender identity, sexual orientation, or Veteran status.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.