Senior Engineer

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 60 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.The Senior Manufacturing Engineer role will support the Irvine Implant Manufacturing plant for 2nd Shift (Mon-Fri, 1:00 p.m. to 10:00 p.m.), including the RESILIA and Final Pack value streams. This role provides technical 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. This 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 Director of RESILIA Manufacturing Engineering and work directly with the Managers of Quality and Operations as well as the Manager of Final Packaging Manufacturing Engineering.Key Responsibilities: 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) Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workMinimum Qualifications: Bachelor's Degree in Engineering or Scientific field with 4 years of experience required OR Master's Degree in Engineering or Scientific field with 3 years of experience OR Ph.D. in Engineering or Scientific fieldPreferred Qualifications: Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills at all levels of employees, suppliers, and consultants. Basic understanding of statistical techniques Previous experience working with lab/industrial equipment required (if applicable) Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Knowledge of applicable FDA regulations for medical device industry Strict attention to detail 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 projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Class II and Class III medical device manufacturing experience is preferred. Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, regulatory guidelines, and process validation.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $101,000 to $142,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.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.