Senior Quality Engineer- Technical Transfer -Medical Devices

Senior Quality Engineer - Technical Transfer - Medical Devices #0571 Springfield, MA

Join to apply for the Senior Quality Engineer – Technical Transfer – Medical Devices #0571 Springfield, MA role at 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 them transformative solutions with distinctive, sustainable and long term value. ECI boasts 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.

The Senior Quality 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 quality‑engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. This role requires up to 50% travel on an as needed basis.

• Support process validation, equipment qualification, and documentation transfer
• Product technical guidance on equipment validation strategies
• Drive continuous improvement in transfer processes to ensure timely completion of deliverables and ensure product quality
• 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 ECI’s client processes or other documentation as directed
• Drive completion of quality activities within prescribed timelines

• Bachelor’s degree in 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
• 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

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.