Design Assurance Engineer

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

When joining PerkinElmer, 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 OneSource services.

Job Title

Design Assurance Engineer

Location(s)

Covaris - Woburn - MA

Job Description

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.

Equal Opportunity and Diversity

PerkinElmer 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.

PerkinElmer is committed to a culturally diverse workforce.

Company Culture

When you work at PerkinElmer, 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?