4 jobs found

Position Summary: We are looking for a highly technical Staff Systems Engineer who will play a key role in the design and development dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will lead systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills. Core Responsibilities: Leads the development and maintenance of system architecture, product specifications, requirements documents, build instructions, acceptance test specifications, V&V documentation, and other technical documentation. Provides technical leadership for product development, integration, testing, and reliability improvements. Leads modeling-based design and development and systems engineering activities. Work with experts across Fresenius Medical Care to integrate new tools into design and development...

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...

Job Description Are you ready to revolutionize Cell & Gene Therapy? Join us in shaping the future of therapeutics! We are seeking a Senior Mechanical & Automation Engineer in our journey of developing cutting-edge manufacturing solutions for Casgevy-a first-of-its-kind therapy transforming the treatment of Sick Cell Disease and Beta Thalassemia. In this role, you will be at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. By leveraging your expertise in mechanical engineering and automation, you will play a pivotal role in streamlining manufacturing, enhancing manufacturing reliability, and scaling life-saving therapies to reach patients faster. You will work with a passionate team of scientists, engineers, and innovators, all united by a shared mission: to push the boundaries of what's possible in Cell & Gene Therapy. This role reports to the Associate Director of Automation, Equipment, and...