36 project engineer ii jobs found

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. We're dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We're working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us as an Engineer II, R&D, and be part of...

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's...

Job Summary Take the lead in driving manufacturing excellence for Insulet's innovative Omnipod® platform in a highly automated, high-volume medical device environment. This role offers the opportunity to lead process improvements, equipment validations, new product introductions, and continuous improvement initiatives that directly impact product quality, efficiency, and patient outcomes. Ideal for engineers with strong Lean Six Sigma, statistical analysis, automation troubleshooting, and project management expertise, this position provides the chance to work cross-functionally with Operations, Quality, Controls, and Engineering teams while supporting cutting-edge manufacturing technologies in a fast-growing global organization committed to improving the lives of people with diabetes. 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...

Job Summary Take the lead in driving manufacturing excellence for Insulet's innovative Omnipod® platform in a highly automated, high-volume medical device environment. This role offers the opportunity to lead process improvements, equipment validations, new product introductions, and continuous improvement initiatives that directly impact product quality, efficiency, and patient outcomes. Ideal for engineers with strong Lean Six Sigma, statistical analysis, automation troubleshooting, and project management expertise, this position provides the chance to work cross-functionally with Operations, Quality, Controls, and Engineering teams while supporting cutting-edge manufacturing technologies in a fast-growing global organization committed to improving the lives of people with diabetes. Job Title: Manufacturing 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...

We believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters - it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion. Who We're Looking For: As a key member of the R&D team, the Senior R&D Engineer will work cross functionally to complete product design, new product development, and manufacturing activities for drug coated catheter combination medical devices. Additionally, this position will facilitate...

We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Our Team, Your Impact For the Device Engineer II we are seeking a motivated and detail-oriented early-career engineer to join our Combination Product Development team. You will support the development and testing of drug delivery systems including prefilled syringes (PFS), auto-injectors (AI), on-body injectors, and other combination products. This is an ideal opportunity for a recent graduate (Master's level) or early-career professional...

Cresilon ® is a Brooklyn-based biotechnology and medical device company that develops, manufactures, and markets hemostatic products, driven by a singular mission: to save lives . Powered by proprietary plant-based hydrogel technology, Cresilon's products are redefining the standard of care by stopping bleeding in seconds across diverse patients, procedures, and care settings. The company's current commercial portfolio includes TRAUMAGEL® for human trauma and VETIGEL® for veterinary applications, with planned expansion into human surgical applications and beyond. Learn more at www.cresilon.com Description: The Senior Medical Device R&D Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control...

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...

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. JOB SUMMARY The Manufacturing Mechanical Engineer II is responsible for developing, implementing, and continuously improving manufacturing processes for mechanical and electromechanical products, with a focus on quality, efficiency, cost, and repeatability. This role applies mechanical engineering expertise and DFO principles to develop tooling, fixtures, equipment, automation, documentation, and process controls that support sustainable low-cost production. The Manufacturing Engineer works closely with Engineering, Quality, Operations, Supply Chain, and suppliers to support new product introduction, resolve manufacturing issues, and implement process improvement and new equipment. ESSENTIAL DUTIES AND RESPONSIBILITIES Lead continuous improvement and cost-reduction initiatives using structured problem-solving, documentation...

Starkey is hiring a Mechanical Engineer II - Continuation Engineering at its global headquarters in Eden Prairie, MN. This position under general supervision, the team member is responsible for executing mechanical engineering changes to released hearing aid products and production tooling within the CE organization. The Mechanical Engineer II - CE drives quality improvements, cost reductions, supply chain continuity, and manufacturing scalability initiatives by designing and validating updated mechanical components, assembly tooling, and fixtures. Has close collaboration with CE Electrical, Systems Verification, Quality, Supply Chain, R&D, and Manufacturing teams to ensure all changes maintain product integrity and comply with Starkey's design control and regulatory requirements. Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day...

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. Job Overview This position serves as a technical leader and subject matter expert for packaging systems, labeling, and sterile barrier solutions supporting Cardiac Surgery and Vascular Intervention product portfolios. This role drives the development, validation, commercialization, lifecycle management, and continuous improvement of complex packaging systems while ensuring compliance with global regulatory requirements. The Staff Packaging Engineer provides strategic technical leadership across multiple programs, mentors engineers, influences packaging standards and...

Description We are hiring an Engineering Manager! The Engineering Manager position is responsible for both the tactical and strategic facets of cost reduction efforts, sustaining activities, and system improvements. Cost Improvement Engineering involves existing products being methodically evaluated on cost by means of function, design, and ease of manufacture and assembly. This position will manage engineering support for cost improvement, providing deliverables on time and within established budgets. Sustaining Engineering focuses on product, process, and/or supply chain changes to maintain the existing revenue stream. This position will work both directly with their immediate team and with other functional groups to ensure risk to raw material supply, and any compliance gaps are mitigated. This Engineering Manager position will facilitate the growth and development within their respective team. Essential Responsibilities: • Serves as Project Lead for highly complex...

Job Summary 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, and...

Requisition ID: 7089 Job Title: R&D Principal Engineer - Alpharetta, GA Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions...

Job Description: POSITION SUMMARY Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships. The Senior Project Engineer will lead the design, development, and implementation of complex medical devices, including capital equipment, disposables, and software-enabled systems for use in organ transportation and preservation. This role will work cross-functionally to ensure product performance, safety, and compliance with regulatory requirements, from concept through commercialization. The Senior Project Engineer serves as a technical leader, mentor, and key contributor to new product development initiatives. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Lead end-to-end project execution for complex medical device systems that integrate capital equipment, disposables, and embedded software components. Develop and manage comprehensive program plans,...

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives - beginning with our own. That's the power of the Cleveland Clinic Health System team, and The Power of Every One. Job Title Facilities Engineer II Location Cleveland Facility Cleveland Clinic Main Campus Department Engineering-Operations Job Code T98302 Shift Days Schedule 8:00am-5:00am Job Summary Job Details Join Cleveland Clinic's Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world-class, and caregivers are family. Cleveland Clinic is recognized as one of the top hospitals in the country. You will work alongside passionate and dedicated caregivers, receive endless support and appreciation, and build a...

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...

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. 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 to reside within a reasonable commuting distance of the designated work location...

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. The Manufacturing Engineer will work closely with SI-BONE's Product Development Team and outsourced manufacturing suppliers to create, improve, implement and document processes and procedures to manufacture, package and label the company's products. In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above. The Manufacturing...