What are the responsibilities and job description for the TMV Engineers position at Medical Engineering Consultants (MEC)?
Job 2509 Equipment Qualification (TMV)- Contract located near Albany, NY
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations
About The Role
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.
Your Responsibilities
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.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of MEC and will not be obligated to pay a placement fee.
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
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.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations
About The Role
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.
Your Responsibilities
- 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.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of MEC and will not be obligated to pay a placement fee.
Check us out at www.medicalengineeringconsultants.com
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
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.