Design Assurance Engineer
Summary
Lead design assurance for new-product and sustaining-engineering projects, coordinating with R&D, Engineering, Manufacturing, Quality, and Commercial teams. Manage design history and transfer deliverables, FMEA-based risk management, validation, and compliance with ISO 13485, ISO 14971, and IEC 60601.
Covaris, LLC., a PerkinElmer company, is a profitable and rapidly growing technology company headquartered in Woburn, Massachusetts.Covaris developed the proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, holding a leadership position in sample preparation for DNA sequencing and providing significant benefits to drug delivery and formulation development. For more information, visit www.covaris.com.
Summary:
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 for on multiple development teams. You will be involved in multiple ongoing projects, including reagents, kits, consumables and instruments manufactured by Covaris in Massachusetts.
Essential Responsibilities:
The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity:
· 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
Preferred Qulaifications:
· 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 Boston area
Reasonable Accommodation:
Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals