87 manager quality validation engineering jobs found

ABOUT ORGANOX: OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life...

JOB SUMMARY: The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations. Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for the facility. A Senior Automation Engineer is responsible for providing technical support for ongoing operations by serving as a system owner for Facilities automation systems, maintaining the site in a compliant state, and ensuring engineering and quality standards are maintained. Facilities Engineering is responsible for the generation and implementation of Change Controls, Corrective Actions Preventive Actions, Deviations, and other quality system records. As a part of project execution, a Senior Automation Engineer will support the design, implementation,...

Essential Responsibilities The purpose of this position is to lead research, design, and development activities for new and existing medical devices manufactured in Tempe, Arizona. As a senior member of the Engineering team, responsibilities will include leading New Product Development (NPD) projects from concept through design transfer with emphasis on design controls, risk management, and cross-functional execution: Lead new product development (NPD), product change, and design enhancement projects from concept through design transfer, ensuring scope, schedule, budget, and technical objectives are met. Own and execute design control activities, including user needs, design inputs, design outputs, design reviews, design traceability, and design history file (DHF) documentation. Translate customer, clinical, regulatory, and manufacturing requirements into clear product specifications and measurable acceptance criteria. Develop product concepts, CAD models, assemblies,...

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 Manufacturing Engineering team you will play an...

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 Research and Development Team you will play an...

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 Manufacturing Engineering Team, you will play an...

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 Research and Development Team you will play an...

Job Description About CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. Work location: Stafford, TX (on-site) Scope: The Manager, Manufacturing Engineering will provide leadership for multiple...

Sulzer is a leading engineering company with a proud heritage of innovation. Join our global team to grow your expertise and develop innovative solutions that enable a prosperous and more sustainable society. About the role Job Summary The (Mechanical) Engineering Expert is responsible for leading the design, development, and optimization of mechanical systems and components. This role provides expert-level technical leadership in mechanical engineering, ensuring that products meet performance, reliability, and cost targets. The expert collaborates across departments to drive innovation and resolve complex engineering challenges. This job profile is intended for recognized subject matter experts in a job area. Required to manage large projects or processes with limited oversight from manager. Coaches, reviews and delegates work to lower level professionals. Position Summary: Lead design, development, and testing and the implementation of innovative products and technologies....

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We're looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential? The Position This position is a leader for all technical, quality and project issues within the Automation Engineering team at our manufacturing facility. This person is responsible to provide...

Working Location: Minnesota, Brooklyn Park Workplace Flexibility: Onsite For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers. Job Description The Senior Engineering Technician II supports the implementation, troubleshooting, maintenance, and continuous improvement of manufacturing equipment, processes, and production systems in an ISO 13485 regulated medical device environment. Working independently and with cross-functional teams, this role assists in the development and maintenance of manufacturing documentation, supports...

Working Location: Massachusetts, Westborough Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers. Job Description The Principal Engineer is responsible for performing and/or leading all aspects of Sustaining including technical planning, feasibility studies, device development, investigations and corrective actions, cost reductions, verification, and validation activities. The primary responsibility of the position is the technical maintenance of the Design History File and Technical Files post...

Working Location: Massachusetts, Westborough Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers. Job Description The Sr. Engineer is responsible for performing and/or leading all aspects of Sustaining including technical planning, feasibility studies, device development, investigations and corrective actions, cost reductions, verification, and validation activities. The primary responsibility of the position is the technical maintenance of the Design History File and Technical Files post launch....

Description Lead Mechanical Engineer Location: Hazelwood, MO Department: Mechanical Engineering Reports To: Associate Director - Mechanical Engineering Position Summary Local Position Summary This lead engineer works primarily with the mechanical design aspects of consumables and reagents team, representing Systems Development in reagent design - generally under the leadership of a principal engineer or functional manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company. Primary Duties Local Position Duties Lead R&D Activities for New Product Introduction (NPI) for the VITEK...

Ever wonder how your engineering leadership could transform complex customer requirements into innovative custom solutions? Design Engineering Manager Morrisville, NC 27560 Full-Time | Exempt Are you a hands-on engineering leader who thrives at the intersection of technical innovation, team leadership, and customer collaboration? Join our team as a Design Engineering Manager, where you will lead a team of design engineers responsible for developing custom hardware solutions that meet customer needs while ensuring quality, compliance, and operational excellence. In this role, you will oversee engineering design activities from concept through testing and documentation while managing engineering resources, collaborating with cross-functional teams, and supporting the successful delivery of customized products. You'll serve as a key technical leader working closely with Sales, Project Management, Operations, Quality, Purchasing, and Manufacturing to bring innovative...

Description Lead Mechanical Engineer Location: Hazelwood, MO Department: Mechanical Engineering Reports To: Associate Director - Mechanical Engineering Position Summary Local Position Summary This lead engineer works primarily with the mechanical design aspects of consumables and reagents team, representing Systems Development in reagent design - generally under the leadership of a principal engineer or functional manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company. Primary Duties Local Position Duties Lead R&D Activities for New Product Introduction (NPI) for the...

Job Title : Staff Engineer, THV Research and Development Staff Engineer I, Research and Development Staff Engineer II, Research and Development Staff Engineer III, Research and Development Supervisor/Manager Title: Director, Research and Development Job Description Summary: Responsible for the development of novel subsystems and components for transcatheter heart valves and/or delivery systems. Job Responsibilities: Conceive, design, and develop components and subsystems of moderate/high complexity for transcatheter heart valves and/or delivery systems in accordance with quality system requirements and with minimal supervision. Create, review and/or approve component and subsystem drawings/specifications and documentation. Identify/evaluate vendors, procure components and develop component specifications. Develop test methods, conduct testing, and interpret data. Conduct engineering analyses and feasibility testing of components and subsystems to...

Job Title : Senior Engineer, THV Manufacturing Senior Engineer I, THV Manufacturing Senior Engineer II, THV Manufacturing Senior Engineer III, THV Manufacturing Supervisor/Manager Title: Senior Global Manager, Manufacturing Engineering Job Description Summary: Responsible for manufacturing engineering tasks associated with sustaining clinical/commercial valve (THV) production line. Job Responsibilities: Provide real-time production line support, such as daily GEMBA walks, equipment troubleshooting, daily tiered meetings, material review board. Develop and optimize manufacturing processes to increase efficiency and quality of products, using lean manufacturing engineering principles. Develop training and documentation materials (e.g., work instructions) for production to enable the seamless transfer of new product/processes to manufacturing. Generate, analyze and summarize data to identify improvement opportunities or to determine appropriate limits...

About Us Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We're developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system. Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure. At the core of our company's identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours. Our product: https://vimeo.com/176673475 About...

Linde Advanced Material Technologies Inc. Senior Engineering Project Manager Indianapolis, IN, United States | req29551 What you will enjoy doing* You will lead the planning and execution of capital and operational projects, ensuring scope, schedule, cost, and quality targets are consistently met In this role, you will coordinate cross-functional project teams, working closely with operations, engineering, contractors, and suppliers to drive successful outcomes You are an expert in managing project schedules and milestones, proactively identifying risks, resolving issues, and mitigating delays Further you will oversee project budgets and financial performance, tracking costs, reviewing invoices, and ensuring alignment with approved estimates You will perform site visits and inspections, verifying construction quality, safety compliance, and adherence to engineering specifications Additionally, you will prepare, review, and manage technical documentation including...