Sr. Manufacturing Engineer, Critical Care

Sr. Manufacturing Engineer, Critical Care

02 Feb 2024
California, Irvine, 92602 Irvine USA

Sr. Manufacturing Engineer, Critical Care

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.For decades, Critical Care has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.With this impactful vision in mind, we are now embarking on becoming an entirely independent business from Edwards Lifesciences (NYSE: EW), a process that is on track to be completed by January 2025.As Critical Care transitions to NewCo, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with 11% revenue re-invested in R&D, and strong sales growth and profitability. We will be well-positioned to pursue our focused strategy and build upon our category leadership in three important ways:

Accelerating the shift from classic monitoring solutions to smart monitoring technologies;

Launching new, AI-enabled connected platforms to support our portfolio of products; and

Expanding into additional care settings with new, non-invasive monitoring technologies.

So, if you're a dynamic and passionate person, eager to contribute to a leading advanced monitoring company, we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-generation’ journey to improve the quality of care and outcomes for millions of patients around the world.Appendix:For further detail on the spin-off from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99:https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspxKey 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 work Other incidental duties assigned by LeadershipEducation and Experience:Bachelor's Degree in Engineering or Scientific field with, 4 years experience years experience including either industry or industry/education Required orMaster's Degree or equivalent in Engineering or Scientific field with, 3 years experience years experience including either industry or industry/education Required orPh.D. or equivalent in Engineering or Scientific fieldwith industry experience or industry/education RequiredAdditional Skills: 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 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 applicable FDA regulations for medical device industry Strict attention to detail 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 projects 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/controlAligning 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 $103,000 to $146,000 (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.

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