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Design Assurance Engineer

Job in Woburn, Middlesex County, Massachusetts, 01813, USA
Listing for: PerkinElmer
Full Time position
Listed on 2026-08-07
Job specializations:
  • Engineering
    Quality Engineering, Manufacturing Engineer, Regulatory Compliance Specialist, Biomedical Engineer
Salary/Wage Range or Industry Benchmark: 90000 - 130000 USD Yearly USD 90000.00 130000.00 YEAR
Job Description & How to Apply Below

When joining Perkin Elmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and One Source services.

Job

Title

Design Assurance Engineer

Location(s)

Covaris - Woburn - MA

Job Description

Covaris, LLC., a Perkin Elmer 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

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.

Equal Opportunity and Diversity

Perkin Elmer is committed to creating a diverse environment and is proud to be an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law.

Perkin Elmer is committed to a culturally diverse workforce.

Company Culture

When you work at Perkin Elmer, that’s exactly what you’ll do.

From our dedicated scientists and world-class operations employees to our innovative R&D professionals and committed sales and service groups, we’re a unique team of 5,000+ global colleagues who come to work every day knowing we’re making a difference.

Through innovation, collaboration, and believing in our mission, we strive to create an inspiring and inclusive culture for our employees, so that they can be their best and, together, create a better tomorrow.

Are you ready to help improve the lives of millions of people and create a healthier world?

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