Highlights
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. 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.
Numbers & Facts
| Location | Woburn, Massachusetts |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 5,000 to 9,999 employees |
| Website | http://www.perkinelmer.com/ |
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 EngineerLocation(s)
Covaris- Woburn- MAJob 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
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.About Company
A healthier future starts with the work we do today
At PerkinElmer, we design, manufacture and deliver advanced technology solutions that address the world's most critical health and safety concerns, including maternal and fetal health, clean water and air, and safe food and toys.
Our expertise combines science, innovation and a culture of operational excellence to offer our customers technology services and support that improve the quality of people's lives worldwide.
A Leader in Human Health
Whether it's testing newborns for life-threatening disorders, supporting scientists in finding better cures, or helping doctors treat disease, our focus on human health extends beyond the lab and into hospitals and homes. With our innovative screenings and treatments, and our ongoing development of advanced life science tools, we help generate earlier medical insights, more accurate results, and more effective therapies.
A Leader in Environmental Health
Our work in environmental health improves the quality and sustainability of our environment, and the security of people in the places where we live, work and play. This includes providing the analytical instrumentation, and services that ensure clean air and water; safe food and consumer products; and efficient, renewable energy - the essential components of a healthier, safer today and tomorrow.