ECI
Senior Process Engineer - Technical Transfer - Medical Devices #0573 Taunton, MA
ECI, Taunton, Massachusetts, us, 02780
Senior Process Engineer - Technical Transfer - Medical Devices #0573 Taunton, MA
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Business Consulting and Services
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing transformative solutions with distinctive, sustainable and long‑term value. We boast a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the Role The Senior Process Engineer will support cross‑functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. You will work in fast‑paced cross‑functional teams to maintain and support manufacturing process engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as‑needed basis.
What You’ll Do
Develop and execute validation protocols during tech transfer, including installation, operational, and performance qualification.
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and enhance operational efficiencies.
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
Ensure products and processes meet specific standards.
Provide support for testing, analysis, and continuous improvement.
Support updates to client processes or other documentation as directed.
Drive completion of process engineering activities within prescribed timelines.
Manage injection molding machines and molds (very large equipment).
What You Will Bring
Bachelor’s degree in mechanical engineering, life sciences, or related field.
8+ years of experience in medical device manufacturing, product development, or technology transfer.
Proven track record supporting complex, multi‑site projects in a regulated environment.
Strong knowledge of design control, process validation, and manufacturing scale‑up.
Results‑oriented, positive attitude focused on delivering timely, accurate, and best‑in‑class execution.
Exceptional communication, collaboration, and problem‑solving skills.
Experience with plastics processing, such as molding and/or extrusion.
ECI is an equal‑opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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Employment type: Full‑time
Job function: Management and Manufacturing
Industries: Business Consulting and Services
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing transformative solutions with distinctive, sustainable and long‑term value. We boast a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the Role The Senior Process Engineer will support cross‑functional teams in transferring equipment used in the production of medical devices to consolidate manufacturing operations, ensuring compliance with regulatory requirements, quality standards, and business objectives. You will work in fast‑paced cross‑functional teams to maintain and support manufacturing process engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as‑needed basis.
What You’ll Do
Develop and execute validation protocols during tech transfer, including installation, operational, and performance qualification.
Drive continuous improvement in transfer processes to ensure timely completion of deliverables and enhance operational efficiencies.
Ensure compliance with FDA, ISO 13485, and other applicable regulatory standards.
Ensure products and processes meet specific standards.
Provide support for testing, analysis, and continuous improvement.
Support updates to client processes or other documentation as directed.
Drive completion of process engineering activities within prescribed timelines.
Manage injection molding machines and molds (very large equipment).
What You Will Bring
Bachelor’s degree in mechanical engineering, life sciences, or related field.
8+ years of experience in medical device manufacturing, product development, or technology transfer.
Proven track record supporting complex, multi‑site projects in a regulated environment.
Strong knowledge of design control, process validation, and manufacturing scale‑up.
Results‑oriented, positive attitude focused on delivering timely, accurate, and best‑in‑class execution.
Exceptional communication, collaboration, and problem‑solving skills.
Experience with plastics processing, such as molding and/or extrusion.
ECI is an equal‑opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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