121 validation engineer jobs found

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Description: This position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment. The role demands deep technical expertise across the full validation lifecycle - including URS development, FAT/SAT...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Description: This position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment. The role demands deep technical expertise across the full validation lifecycle - including URS development, FAT/SAT...

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Description: This position supports equipment design and process implementation activities under the guidance of the Staff Engineer. The Senior Engineer leads the design, development, validation, and integration of manufacturing equipment, ensuring full alignment with project requirements, regulatory standards, and operational excellence in a GMP-regulated environment. The role demands deep technical expertise across the full validation lifecycle - including URS development, FAT/SAT...

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects. Supports Validation objectives, whilst adhering to regulatory compliance and achieving commercial success. This is a site-based position supporting the facility and will required gowning into the manufacturing suites. Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met. Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and objectives, whilst adhering to regulatory compliance and achieving business...

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Quality Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine. You will also support the IHFM team by managing engineering...

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...

Apptronik is a human-centered robotics company developing AI-powered robots to support humanity in every facet of life. Our flagship humanoid robot, Apollo, is built to collaborate thoughtfully with people, starting with critical industries such as manufacturing and logistics, with future applications in healthcare, the home, and beyond. We operate at the cutting edge of embodied AI, applying our expertise across the full robotics stack to solve some of society's most important problems. You will join a team dedicated to bringing Apollo to market at scale, tackling the complex challenges like safety, commercialization, and mass production to change the world for the better. Job Summary We are seeking a Staff Mechanical Engineer to lead the structural design and architecture of a next-generation robotic hand for a humanoid platform. This role goes beyond traditional end effectors-focusing on highly dexterous, human-like manipulation in unstructured environments. As the...

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. The responsibilities of the position include, but are not limited to, the following: Obtaining market feedback from surgeons and other customers to determine functional and design specifications for new product development Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project Managing all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality...

Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come. TITLE: Senior NPI Process Development Engineer POSITION SUMMARY: The Senior NPI Process Development Engineer will focus on further developing our product and then transferring it into a manufacturing setting. The successful candidate will possess a passion for medical device engineering and a record of successful process, tooling and equipment design. This role will engage in cross-functional collaboration to accelerate the product development process, reduce cost of goods, and enable more complex designs through manufacturing...

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience-designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care...

Title: Senior Manufacturing Engineer Location: Lake Zurich Employment Type: Full-Time About Us Founded in 1996, Medical Murray is a privately owned medical device company specializing in the development, testing, and manufacturing of finished devices, components, and subassemblies. We partner with clients ranging from innovative startups to the world's largest OEMs. Our expertise includes permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our culture is driven by five core values: Helpful, Happy, Personal Responsibility, Trustworthy and Clever & Skillful. These principles guide our work, our relationships, and our commitment to improving patient outcomes worldwide. Benefits Summary We offer a competitive compensation and benefits package, including medical (BCBS) and dental coverage, company-paid vision and life insurance, short- and long-term disability, HSA-eligible plans,...

Title: Molding Manufacturing Engineer Location: Lake Zurich Employment Type: Full-Time About Us Founded in 1996, Medical Murray is a privately owned medical device company specializing in the development, testing, and manufacturing of finished devices, components, and subassemblies. We partner with clients ranging from innovative startups to the world's largest OEMs. Our expertise includes permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our culture is driven by five core values: Integrity First, People Matter, First-Class Service, Inspired Innovation, and Community Service. These principles guide our work, our relationships, and our commitment to improving patient outcomes worldwide. Benefits Summary We offer a competitive compensation and benefits package, including medical (BCBS) and dental coverage, company-paid vision and life insurance, short- and long-term disability,...

Who We Are ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com. What You'll Do At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself. As a key member of the Foot & Ankle Research & Development team you...

Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Position Description The Tooling Design Engineer III plays a critical role in supporting extrusion manufacturing by designing, modifying, and sustaining tooling used in production. This role contributes directly to product quality and manufacturing efficiency by developing robust tooling solutions, improving existing designs, and supporting troubleshooting efforts across extrusion processes. The engineer partners closely with manufacturing and process...

Who We Are ABOUT ENOVIS™ Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com. What You'll Do At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it. Because that's how we change the lives of patients for the better. And that's how we create better together. As a key member of the NPI Manufacturing Engineering group you will play an integral part in helping Enovis drive the...

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary: The Project Engineer will be responsible for all engineering functions of their product lines. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This individual will work closely with spine surgeons and all other functions of the company to ensure high quality and on-time...

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...

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 30 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description The Design Engineer II contributes to Applied Medical's Technology and Development Mechanical team by designing and developing medical device components, assemblies, and fixtures that directly support the advancement of surgical technology. Working onsite at Applied Medical's global headquarters, this role operates within a cross-functional team environment to take products from concept through detailed design, documentation, and...

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...