20 process development engineer 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...

Corin is seeking a Process Engineer for Technology to work in our Raynham, MA facility. This role will lead manufacturing process development, optimization, standardization, and maintenance within the Technology Manufacturing team at Corin. The role aims to achieve world-class performance through standardization and automation by improving and implementing end-to-end operational processes. The key responsibilities of the Process Engineer, Technology are/to: • Develop, implement, and optimize best practices for technology based processes. • Bring Technology based products from development to full scale manufacture. Creating, trialing and rolling out processes to production. • Drive the implementation of new and optimized processes to ensure robust and repeatable operational improvements. • Manage product and process changes with a focus on patient safety, operational safety, and device performance. • Manage bill of materials to ensure all required assemblies and subcomponents...

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community. The...

Compensation: Salary Range depending on experience and qualifications. Role Overview Arrotek USA is seeking an experienced Sr Catheter Engineer specializing in catheter and guidewire design and process development. In this pivotal role, you will support the design, development, and commercialization of advanced interventional medical devices. This position is part of a rapidly growing Design Services organization and requires a hands-on engineer with strong technical depth, problem-solving ability, and client-facing communication skills. You will be involved in every stage of the medical device lifecycle - from concept development and prototyping to process development, verification/validation, and design transfer. Collaboration with cross-functional teams and external clients in a fast-paced, fee-for-service environment is central to this role. Key Responsibilities Design and develop innovative catheter and guidewire technologies, including concept generation,...

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...

Associate Systems Engineer Job Description: Position Summary The Associate Systems Engineer position is designed to provide the selected candidate with a broad exposure to the design and development process for wearable medical devices that are used by patients around the world on a daily basis. This position will be an integral member of the R&D team directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology. This role will provide exposure to several aspects of Insulet's design control processes including but not limited to writing and interpreting product requirements, device integration, verification test methods, troubleshooting/design analysis, and design documentation. Responsibilities Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement. Support all phases of the design and development lifecycle of a medical device Participate in product design or technical...

Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit. Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business. The Manufacturing Engineer II will have responsibility to support the day-to-day operation of automated production equipment at RMB, Lowell. This...

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...

Injection Molding Engineer Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise. We are currently seeking Engineering candidates to add to our growing team. DUTIES Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps. Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team with details of root cause analysis....

About UFP Technologies : UFP Technologies is a designer and custom manufacturer of comprehensive solutions for medical devices, sterile packaging, and other highly engineered custom products. UFP is an important link in the medical device supply chain and a valued outsource partner to most of the top medical device manufacturers in the world. The Company's single-use and single-patient devices and components are used in a wide range of medical devices and packaging for minimally invasive surgery, infection prevention, wound care, wearables, orthopedic soft goods, and orthopedic implants. UFP Technologies, Inc. offers a competitive benefits package, including but not limited to: Medical, Dental, Vision, Life, Disability Insurance 401K with a matching contribution Paid time off, Paid holidays, Employee discounts and much more! Location: This position will be on-site full-time in Newburyport, MA. Applicants must be authorized to work for any employer in the U.S. At this...

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 Hologic's Breast & Skeletal Health division is seeking a Lead Electrical Engineer, NPD to drive the design and development of electrical systems for our next-generation imaging platforms. In this role, you'll be a senior technical leader, owning architecture and design for complex medical devices that directly impact patient care. What You'll Do Lead the design, development, and testing of electrical and electronic systems and subsystems for medical imaging products. Own electrical architectures and specifications, ensuring designs meet safety, quality, and regulatory requirements. Design and guide development of PCBs, power electronics, motors (BLDC/Stepper), feedback and protection circuitry, and cable/harness assemblies. Develop schematics (Cadstar/OrCAD) and work with PCB layout tools (Cadstar, PADS, OrCAD Allegro, Altium). Analyze and optimize image chain and system performance, driving design, cost, and time-to-market improvements. Build...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next...

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...

Job Description: POSITION SUMMARY The Senior Mechanical Sustaining Engineer will be supporting cross-functional sustaining engineering project teams. This is an important role for the company, providing engineering expertise to support products already on the market. The position requires a team-oriented individual with strong engineering RESPONSIBILITIES This position is responsible for, but not limited to, the following: Serve as hands-on, technical contributor in developing new products to support existing product lines with minimal oversight Document designs by constructing solid models, assemblies, and drawings with SolidWorks Fabricate prototypes utilizing internal and external resources Perform structural, dimensional, fluid, vibration, thermal, and reliability analyses to support new and existing product designs Work with internal and external manufacturing partners to ensure design for manufacturability and serviceability Prepare and lead design reviews, and...

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite Position Overview: Insulet is the world's leading manufacturer of high-volume, disposable, electromechanical, wearable medical devices. As an Automation Engineer (Onsite) in the Global Equipment Engineering Group, the candidate will support the design, development, and improvement of automated manufacturing equipment used in high-volume production of wearable medical devices. Working under the guidance of senior engineers, you will contribute to projects involving assembly automation, packaging equipment, continuous improvement, and new product introduction. The candidate will also collaborate with internal customers and external vendors to specify, procure, and install new manufacturing lines and equipment in accordance with business needs. The candidate will work in a collaborative team environment with manufacturing, manufacturing engineering, controls, metrology, quality, and...

Job Title: Manager, Manufacturing Engineering (Onsite) Department: Global Manufacturing Engineering FLSA Status: Exempt Company Overview Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe. We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued...

Job Description General/Position Summary: The Director, Facilities Engineering is a pivotal role within Global Operations & Real Estate department, with a wide range of responsibilities for the company's real estate portfolio, which consists of research and development, GMP manufacturing, office, and other types of facilities. The role oversees and manages the Project Engineering, GMP Site Engineering, Advanced Manufacturing Engineering, and Engineering Documentation teams ensuring effective leadership, performance management, and alignment with organizational goals. The Facilities Engineering group works very closely with all levels of the Capital Project Management Office (PMO), Facilities & Operations, and various GMP manufacturing teams. The Director leads the development and implementation of company-wide engineering management processes, establishes facility design guidelines, policies, and standard operating procedures, spearheads energy resource reduction...

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details Job Summary We are seeking an experienced and creative-thinking Senior Biomedical Product Development Engineer to join our multidisciplinary Research & Development Systems Engineering team in Boston, MA. In this role, you will serve as the primary owner of the mechanical design and functional performance of disposable components used within the TEG6s in vitro diagnostic (IVD) system. You will play a critical role across the full product lifecycle-supporting both new product development and sustaining engineering initiatives-while collaborating closely with assay development, manufacturing, quality, regulatory, system hardware, clinical, and commercial teams to ensure robust product performance and successful market introduction. Your work will...

Job Description: POSITION SUMMARY The Director of Electrical & Systems Engineering will plan, design, and oversee the electrical and biomedical infrastructure of our organization to ensure those designs are implemented effectively while meeting the needs of the business and adhering to industry standards. This role also involves leading and mentoring a team of electrical and biomedical engineers, developing long-range plans, strategies, and driving top-level company objectives. This position is onsite 5 days a week. RESPONSIBILITIES Responsible for the electrical architecture, design and testing for the Next Generation Organ Care System while ensuring compliance with project requirements and regulatory standards. Provide leadership, oversight and guidance to internal and external design teams for new and legacy products, complaint investigations, and obsolescence. Possess a hands-on approach to developing electrical engineering strategies, prototypes and designs for...