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:
1.    Accelerating the shift from classic monitoring solutions to smart monitoring technologies;
2.    Launching new, AI-enabled connected platforms to support our portfolio of products; and
3.    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.aspx

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 work
• Other incidental duties assigned by Leadership

Education and Experience:
Bachelor's Degree in Engineering or Scientific field with, 4 years experience years experience including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field with, 3 years experience years experience including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific fieldwith industry experience or industry/education Required

Additional 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 prioritie