23 validation 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...

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....

Position Overview: Performs engineering work related to planning, devising, or adapting methods to improve process effectiveness at captive and third party manufacturing sites. Examines components, equipment, processes, operations, and finished device design to identify improvement opportunities. Responsibilities: • At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing. • Drive product and process improvements in support of Insulet's CAPA system. • Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports. • Author and implement Engineering Change Orders. • Design and coordinate the construction manufacturing fixtures. • Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing,...

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,...

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...

Acute Care Technology 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 to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a career-and a purpose. Join our team. It's a great time to be a part of ZOLL! Due to the on-site requirements of this position, applicants are expected...

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....

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...

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...

Sun Pharma is the world's fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. Job Summary: This position provides mechanical and electromechanical engineering for sustaining engineering support for existing medical products as well as new projects. Area Of Responsibility: Provide support for existing products, product investigations, and analysis to determine root cause and appropriate resolution of product issues, and support customer requirements Prepare and maintain all necessary product...

Position Dates: July 6, 2026 - December 18, 2026 Job Title: Co-op, Manufacturing Engineering Department: Global Manufacturing Engineering - Acton Insulet Builds New U.S. Manufacturing Facility The $100 Million Investment in Massachusetts will provide for hundreds of local manufacturing jobs at a 350,000 square-foot facility. Insulet is building a brand-new, state-of-the-art manufacturing facility on a 26-acre site in Acton, Massachusetts. The new facility represents a significant investment in Massachusetts, is expected to create hundreds of local jobs, and will provide additional manufacturing capabilities closer to Insulet's large and growing U.S. customer base. The new U.S. manufacturing operation is also expected to drive operating efficiencies and increase productivity. Position Overview: The Global Manufacturing Engineering team is focused on supporting Insulet's manufacturing operations in Insulet's new state of the art high speed automated manufacturing...

Position Dates: July 6, 2026 - December 18, 2026 Grad Co-op Job Description Job Title: Manufacturing Engineering Co-op Department: Global Manufacturing Engineering - Acton FLSA Status: Non- exempt Insulet Builds New U.S. Manufacturing Facility The $100 Million Investment in Massachusetts will provide for hundreds of local manufacturing jobs at a 350,000 square-foot facility. Insulet is building a brand-new, state-of-the-art manufacturing facility on a 26-acre site in Acton, Massachusetts. The new facility represents a significant investment in Massachusetts, is expected to create hundreds of local jobs, and will provide additional manufacturing capabilities closer to Insulet's large and growing U.S. customer base. The new U.S. manufacturing operation is also expected to drive operating efficiencies and increase productivity. Position Overview: The Global Manufacturing Engineering team is focused on supporting Insulet's manufacturing operations in Insulet's...

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...