Lead Systems Engineer

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Senior Design Quality Engineer Medical Devices | Design Controls & Risk ManagementOnsite Location: Bothell, WA / Cambridge, MA Job Type: Contract Job OverviewWe are seeking an experienced Senior Design Quality Engineer / Design Assurance Engineer with strong experience in FDA-regulated medical device environments. The ideal candidate will have hands-on experience with Design Controls, Design Verification & Validation, Risk Management, CAPA, Change Control, Design Transfer, and Quality Management

Job Description Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of

Summary: We are seeking highly skilled and experienced System Engineers to join our team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. This individual will play a critical role in ensuring that user needs are clearly traced to design inputs, verification, and validation throughout the product development lifecycle. Roles & Responsibilities: Design Controls: Lead efforts to deve