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CEI Group
Woburn
Design Assurance Engineer Responsibilities: Ensuring that the design process complies with relevant regulations and standards such as FDA guidelines, ISO standards, and other applicable regulatory ; Working with the verification and valida...
Job Source: CEI GroupIntegra LifeSciences
Billerica, MA, United States
Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. DUTIES AND RESPONSIBIL
Job Source: Integra LifeSciencesNew Leaf Energy, Inc.
Boston, MA, United States
New Leaf Energy is an experienced clean energy developer that partners with landowners, policymakers, and other stakeholders to accelerate the transition to a world powered by renewable energy. We identify high-value sites, work with landowners and local communities to develop them, and partner with long-term asset owners to bring the most impactfu
Job Source: New Leaf Energy, Inc.ZwitterCo, Inc.
Woburn, MA, United States
Design Engineer I Woburn, MA Overview of Role ZwitterCo is announcing an immediate opening for a Design Engineer I who is seeking a collaborative role as we grow and scale. The ideal candidate will have hands on experience prototyping utilizing the fundamentals of mechanical and electrical design. About ZwitterCo ZwitterCo has developed a breakthro
Job Source: ZwitterCo, Inc.New Leaf Energy, Inc.
Lowell, MA, United States
New Leaf Energy is an experienced clean energy developer that partners with landowners, policymakers, and other stakeholders to accelerate the transition to a world powered by renewable energy. We identify high-value sites, work with landowners and local communities to develop them, and partner with long-term asset owners to bring the most impactfu
Job Source: New Leaf Energy, Inc.Boston Water and Sewer Commission
Boston, MA, United States
Residency Requirement: Employees must be Boston residents on their date of hire and for the duration of their employment subject to BWSC policies and collective bargaining agreements. Overview: Position Purpose : Performs various entry level administrative and technical engineering tasks. Responsible for engineering design and ensures that
Job Source: Boston Water and Sewer CommissionBoston Water and Sewer Commission
Boston, MA, United States
Residency Requirement: Employees must be Boston residents on their date of hire and for the duration of their employment subject to BWSC policies and collective bargaining agreements. Overview: Position Purpose : Performs professional and technical work related to the engineering activities of the Commission. Responsible for project ma
Job Source: Boston Water and Sewer CommissionVaco
Chelmsford, MA, United States
Design Engineer Direct Hire Onsite Requirements: Bachelor's degree in engineering The job holder must be US Citizen or Permanent Resident. Advanced design skills Product-focused creative thinking In-depth knowledge of industry design principles Strong working knowledge of computer-aided design (CAD) or engineering software Impeccable attention
Job Source: VacoWoburn, MA, United States
Our client is a leading innovator in the healthcare industry, specializing in the development and production of cutting-edge medical devices. Their mission is to improve patient outcomes and quality of life through advanced technology and rigorous quality standards.
Theyare seeking a highly skilled and detail-oriented Design Assurance Engineer to join theirteam. In this role, you will be responsible for ensuring the quality and compliance of our medical device designs throughout the product development lifecycle. You will collaborate closely with cross-functional teams to implement design controls, conduct risk assessments, and drive continuous improvement initiatives.
Key Responsibilities:
Develop and implement design control processes and procedures in compliance with regulatory requirements (e.g., FDA, ISO).
Conduct risk assessments and mitigation strategies for new and existing product designs.
Review and approve design documentation, including design input/output, verification/validation protocols, and design change assessments.
Lead design reviews and provide guidance on design best practices and regulatory requirements.
Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to ensure alignment on design quality and compliance objectives.
Participate in audits and inspections, providing documentation and support as needed.
Drive continuous improvement initiatives related to design assurance processes and practices.
Stay current with industry trends, standards, and regulations related to medical device design and quality assurance.
Qualifications:
Bachelor's degree in Engineering or related field (Master's degree preferred).
2+ years of experience in design assurance/engineering roles within the medical device industry.
Strong knowledge of FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485).
Experience with risk management methodologies (e.g., FMEA, Hazard Analysis).
Proficiency in design control tools/software (e.g., PLM systems, design verification/validation tools).
Excellent communication, collaboration, and problem-solving skills.
Certification in Quality Engineering (e.g., ASQ CQE) is a plus.
Benefits:
Competitive salary and benefits package.
Opportunities for professional development and career growth.
A collaborative and supportive work environment focused on innovation and excellence.
If you are passionate about ensuring the quality and safety of medical devices and want to make a meaningful impact in healthcare, we encourage you to apply for this exciting opportunity.
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Design Assurance Engineer jobs in Woburn, MA, United States
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