24 quality process engineer jobs found

Job Title: Associate Manufacturing Engineer (On-site) Department: 003824 - China Sustaining Engineering FLSA Status: Exempt Position Overview: The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA. The candidate will be based out of Insulet HQ in Acton, MA, but will be expected to travel frequently to manufacturing sites as required to complete project deliverables. This candidate will be work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment. The candidate will use his/her knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful...

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. RESPONSIBILITIES Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages. Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements. Lead troubleshooting efforts and guide the team through detailed root cause analyses. Apply Lean methodologies to...

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. This role is open to US candidates. Paragonix Technologies is a rapidly growing medical device manufacturer which designs, manufactures, and sells organ transplant transport devices. Our dynamic team is committed to improving the lives of transplant patients by providing advanced technologies to ensure optimal preservation for donor organs on the journey to their ultimate recipients. Paragonix also markets services to the transplant community. Job Overview: The company offers a leading commercial system for heart preservation and transportation, while actively...

Acute Care TechnologyThe Senior Service Manufacturing Engineer leads engineering and operational excellence initiatives within ZOLL's medical device repair depot. This role applies manufacturing engineering principles to a service environment, with ownership of repair line performance, resolution of complex production issues, process optimization, and overall operational efficiency. The engineer is responsible for sustaining and improving throughput, yield, and cost, while driving continuous improvement initiatives and partnering cross-functionally to enhance product quality, serviceability, and repair operations. This role plays a critical part in ensuring the scalability, reliability, and cost-effectiveness of ZOLL's global service operations.At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide...

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...

Position Overview The Associate Manufacturing Engineer, Global Engineering, will be a key team member in the growth and ongoing support of Insulet's manufacturing base across the world, at Contract Manufacturer (CM) sites and at Insulet's US Manufacturing facility in Acton, MA. The candidate will use his/her knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new manufacturing equipment and processes. The person will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production. As part of providing support to the Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work...

Job Title: Packaging Engineer, Supplier Engineering FLSA Status: Exempt Position Overview: The Supplier Engineer - Packaging Engineer - is a key member of the Supplier Engineering group, which is part of Insulet's Operations organization. Insulet manages a global supply chain and sources precision components and commodities from around the world for use in its devices. The Supplier Engineer works closely with peers and leaders in Quality, Sourcing and Manufacturing to implement new capital tooling and equipment at suppliers, carry out new product introductions, execute improvement projects, resolve business-critical technical issues, and investigate and lead corrective actions in response to quality issues across the supply base. The ideal candidate has experience developing and implementing custom packaging solutions for components and finished medical devices. Candidate is required to have a direct knowledge of applicable packaging standards used in the medical device industry....

Job Title: Senior Manufacturing Equipment Engineer 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 success depends on it. Position Overview The Senior...

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...

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...

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...

Position Overview: The Plant Manufacturing Engineer is a critical member of the plant engineering and operations teams. This role is responsible for reliability engineering, monitoring, and standardizing the manufacturing process, anticipating and resolving bottlenecks to capacity, driving uniformity of maintenance and operations principles, identifying and implementing cost and waste reductions, and general continuous improvement of the site. The successful candidate will have strong structured problem-solving skills of complex component and machine interactions and be comfortable working hands-on with automation machinery. Responsibilities: Accountable to driving maintenance process improvements in support of Insulet's primary manufacturing objectives: Best Quality, Best Service, Best Cost. Autonomously interprets data to drive plant decision making and prioritization of reliability efforts. Plan, execute, and manage efficiency improvement projects. Develop 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...

Job Description: POSITION SUMMARY TransMedics is transforming organ transplantation through the Organ Care System (OCS), a breakthrough platform that preserves and assesses donor organs outside the body. Our Manufacturing Engineering team plays a critical role in ensuring safe, efficient, and scalable production of both disposable and capital equipment systems. The Manufacturing Engineering Intern will support production-related engineering activities associated with the manufacturing of the TransMedics Organ Care System. This role provides hands-on exposure to assembly processes, test systems, documentation control, and process validation within a regulated medical device environment. The intern will work closely with Manufacturing Engineers and be paired with a dedicated mentor to ensure meaningful project ownership and professional development throughout the program. RESPONSIBILITIES: This position is responsible for, but not limited to, the following: Manufacturing...