> Markdown version of [/jobs/ext/1486951-design-assurance-engineer](https://www.wearedevelopers.com/jobs/ext/1486951-design-assurance-engineer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Design Assurance Engineer

- **Company:** PerkinElmer, Inc.
- **Location:** Woburn, MA, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Failure Mode Effects Analysis, Microsoft Office
- **Published:** July 29, 2026
- **Apply:** https://newperkinelmer.wd1.myworkdayjobs.com/External/job/Covaris---Woburn---MA/Design-Assurance-Engineer_REQ-058101/apply

## About the Role

· 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

## Description

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


## Related Videos

- [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build)
- [Great DevEx and Regulatory Compliance - Possible?](https://www.wearedevelopers.com/videos/1426-great-devex-and-regulatory-compliance-possible)
- [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips)
- [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process)

## Related Articles

- [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development)
- [Events like RSAC Get You CISOs. Developers Decide What Actually Gets Deployed.](https://www.wearedevelopers.com/magazine/693-events-like-rsac-get-you-cisos-developers-decide-what-actually-gets-deployed)
- [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering)
- [Top Characteristics of a Software Engineer](https://www.wearedevelopers.com/magazine/166-top-characteristics-of-a-software-engineer)
- [How software is steering vehicle technology](https://www.wearedevelopers.com/magazine/515-how-software-is-steering-vehicle-technology)
- [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs)