Senior Engineer, Quality

For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) 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 independent business from Edwards, a process that we currently expect to be completed by January 2025.

As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.

So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industryleading 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-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.

Appendix: For further detail on the spin-off of Critical Care 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-InvestorConference-2023-bK2BbXaBha/default.aspx

How You'll Make An Impact:

• Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.

• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

• Develop, update, and maintain technical content of risk management files for NPD and existing products.

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

• Train, coach, and guide lower level employees on routine procedures

• Other incidental duties assigned by Leadership

What You'll Need (Required):

• Bachelor's Degree in in Engineering or related field, 4 years experience related industry experience Required or

• Master's Degree or equivalent in in Engineering or related field, 3 years experience related industry or industry/education experience required.

What Else We Look For (Preferred): 

• Proven expertise in usage of MS Office Suite; Minitab and CAD experience preferred

• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• Working knowledge and understanding of statistical techniques

• Working knowledge of regulatory, ISO, and workmanship standards such as FDA, EUMDR, ISO 13485, IPC-A-610, and IPC-A-620.

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Working knowledge of risk management per ISO 14971

• 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 Quality systems

• 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

• 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