4 quality process engineer jobs found in Andover

Job Description: Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships POSITION SUMMARY We are seeking a results-driven Senior Test Engineer with experience in the medical device industry to join our test engineering team. This role is responsible for developing, executing, and overseeing the testing strategies that ensure the safety, reliability, and compliance of Class II/III medical devices in accordance with FDA and ISO 13485 regulations. The ideal candidate has a deep understanding of medical device lifecycle processes and a strong technical background in test systems, automation, and compliance in regulated environments. This position is based at our Andover, MA headquarters. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead test engineering activities for new development projects. Responsible for conducting feasibility and...

Job Summary Will work with the most advanced Vicor products involved with development, qualification and production release of electronic assemblies and related assembly processes used in commercial, automotive and other specialty products. As a NPI Project Engineer, you will be responsible for taking Vicor advanced products through various stages of new product introduction (NPI) development by working cross functionally across multiple teams. In addition to early involvement with product design team on design for manufacturability, you will also be evaluating and justifying for production readiness and release. Job Description • Will work NPI products that are designed and built using our in house highly automated lines working with technologies such as multi-layer high density PCB designs, leading edge SMT assembly, advanced packaging magnetics assembly, thermal transfer molding, state of the art PCB processing/plating fabrication, laser marking, singulation, and test. •...

Job Description: POSITION SUMMARY: The Sr. Product Development Engineer will develop disposable and durable products for the OCS (Organ Care System) product lines. This position is onsite at our Andover location 5 days. Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Assist Clinical team with development of disposable and accessory concepts. Develop electromechanical sub-systems with cross-functional team. Responsible for CAD design, prototyping, and testing of new concepts and iterating through the design process. Provide guidance to Jr. Engineers, Technicians, External Design teams, and OEM manufacturers. Perform thorough analysis (tolerance, dFMEA, DOE, statistical) to ensure product will meet design requirements. Manage injection mold suppliers through the tool development process and...

Job Description: POSITION SUMMARY: The Principal Engineer - NPI Manufacturing serve as the technical project leader for NPI manufacturing activities, driving the development and commercialization of TransMedics perfusion set and OCS products. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Provide strategic oversight of manufacturing readiness for new product introductions, ensuring alignment of engineering resources, project schedules, and cross-functional deliverables. Lead cross-functional collaboration with Product Development, Quality, Regulatory, Supply Chain, and Manufacturing Operations to ensure robust, scalable, and compliant processes. Coordinate, identify, and implement advanced manufacturing processes to ensure production capacity, efficiency, cost-effectiveness, and adherence to quality standards. Define project plans, timelines, and resources needed to support NPI manufacturing programs, ensuring accountability for...