Edwards Lifesciences Senior Manufacturing Engineer (RESILIA) – 2nd Shift in Irvine, California
Joining Edwards Lifesciences means innovating, pushing boundaries, and being creative while always putting patients first. It means solving challenges with colleagues who share your sense of urgency, optimism, and enthusiasm, colleagues who are just as focused on testing their limits and taking ownership. And it means that you will be empowered to get the job done by taking charge of your work and your career. Innovation is at the core of Edwards! Without it, we would not be able to produce the life-saving products and therapies that transform lives around the world. That is why we surround ourselves with people who are not afraid to question the status quo or express a different point of view.
Edwards Lifesciences is hiring for a Senior Manufacturing Engineer for 2nd shift. The hours are Monday to Friday 1:30pm to 10:30pm. This is a unique opportunity to be part of our high performing production Irvine Implant Plant.
The Senior Manufacturing Engineer role provides support and oversight on commercial class III, implantable devices for Edwards' comprehensive portfolio of treatments for structural heart disease within the Surgical and Transcatheter Heart Valves (THV &TMTT) Business Units. The Senior Engineer will support the Global Supply Chain Network by managing engineering activities from new product introduction, stabilization, and sustaining. The position will report to the Manager of RESILIA Engineering and work directly with the Managers of Quality and Operations.
Essential job functions include:
Accountable for successful commercialization of new products and process ramp up for production released products.
Ensure that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies.
Act as a liaison between NPI, OPs, Quality, Regulatory, and Planning team members assigned to the project.
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Perform other duties and responsibilities as assigned.
Bachelor's Degree in Engineering or Scientific with 4 years of manufacturing engineering experience.
Must be able to work 2nd shift Monday to Friday 1:30pm to 10:30pm.
Master’s degree in Engineering; Mechanical or Biomedical degree preferred.
Class II and Class III medical device manufacturing experience is preferred.
Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
Excellent problem-solving, organizational, analytical, and critical thinking skills.
Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
Proven expertise in Microsoft Office Suite and manufacturing systems.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or project.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.