Design Assurance Engineer

Location: Woburn, Massachusetts, US

About the role

As Design Assurance Engineer, you will lead Design Assurance activities for new product introduction (NPI) and sustaining engineering projects. You will be an active contributor on multiple development teams, involved in ongoing projects including reagents, kits, consumables, and instruments manufactured by Covaris in Massachusetts.

Responsibilities

• Lead design assurance activities for new product development and sustaining engineering projects
• Work closely with R&D, Engineering, and Manufacturing on design, testing, and verification activities
• Represent Quality at Core Team level
• Manage Design History file and Design Transfer deliverables
• Lead risk management activities including FMEA, risk mitigation, and effectiveness checks
• Support design transfer, process validation, and test method validation
• Collaborate with Commercial, Supply Chain, Manufacturing, and Quality teams
• Track and support multiple NPI and sustaining engineering projects
• Drive continuous improvement in quality and design assurance processes

Requirements

• 5+ years of Design Assurance or Product Development experience in a regulated industry (Medical Device, IVD, Aerospace, Automotive, etc.)
• Strong knowledge of new product development and close collaboration with R&D
• Solid understanding of global regulations and standards: ISO 13485, ISO 14971, IEC 60601
• Experience working with cross-functional and global teams
• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field
• Proactive, detail-oriented, and solution-driven
• Proficiency in Microsoft Office
• Must be based in the Boston area