Design Assurance Engineer - NPI & Quality Leader

PerkinElmer; Woburn (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Covaris, LLC., a PerkinElmer company, located in Woburn, MA, seeks a Design Assurance Engineer to lead QA activities for new product introduction and sustaining projects across reagents, kits, consumables, and instruments.

You'll collaborate with R&D, Engineering, and Manufacturing, manage Design History files, and drive risk management and process validation in a regulated environment to support multiple concurrent NPI efforts in Massachusetts.

Qualifications

• 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.

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.

Skills

Design Assurance

Regulatory knowledge

Cross-functional collaboration

Risk management

Microsoft Office

Education

Bachelor's degree in Mechanical, Electrical, Biomedical Engineering

Tools

Microsoft Office

Job description

Covaris, LLC., a PerkinElmer company, located in Woburn, MA, seeks a Design Assurance Engineer to lead QA activities for new product introduction and sustaining projects across reagents, kits, consumables, and instruments.

You'll collaborate with R&D, Engineering, and Manufacturing, manage Design History files, and drive risk management and process validation in a regulated environment to support multiple concurrent NPI efforts in Massachusetts.