Manufacturing Engineer

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company driven by a passion to improve patient lives. With millions of patients served in over 100 countries each team makes a meaningful contribution by improving patient outcomes and delivering lasting solutions for unmet patient needs. OurManufacturing Engineer Iposition offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence.

Imagine how your ideas and expertise can change a patients life. OurManufacturing Engineering Pilotteam plays a critical role in enabling robust scalable manufacturing processes prior to full this role you will partner crossfunctionally with Manufacturing Quality R&D and Operations teams to support pilot production qualify processes and equipment and drive continuous improvement within a regulated medical device environment.

How Youll Make an Impact:

• Contribute as a key member of the Pilot Operations team supporting programs that advance new medical devices from development through commercialization and scaleup.

• Build strong technical and process knowledge to support rapid product development cycles process stabilization and successful technology transfer to global manufacturing sites.

• Develop implement and support Manufacturing Execution System (MES) capabilities for products within the Pilot pipeline ensuring readiness for commercialization and scale.

• Improve manufacturing processes using engineering methods such as Lean fundamentals and basic statistical analysis to drive continuous improvement.

• Design execute and document experiments and tests including writing protocols analyzing results and developing reports to qualify and validate manufacturing processes.

• Analyze and help resolve basic manufacturing and compliance issues including CAPA activities nonconformances and audit observations in alignment with quality and regulatory requirements.

• Create andmaintain training materials and manufacturing documentation including work instructions to support effective knowledge transfer to production teams.

• Develop and manage project plans using standard project management tools including timelines and risk analyses to ensure deliverables meet customer and business expectations.

• Identify opportunities to redesign basic equipment tools fixtures or processes to improve manufacturing performance reliability and scalability.

• Provide daytoday manufacturing support by guidingtechnicians through testing activities training and coaching technicians providing feedback and coordinating technician work.

• Support Pilot Operations leadership with additional responsibilities and tasks as needed to meet evolving business and program needs.

What youll need (Required):

• Bachelors Degree in Engineering or Scientific field

What Else We Look For (Preferred):

• Demonstrated proficiency with standard computer tools including the Microsoft Office Suite (MS Project experience preferred; CAD experience a plus if applicable).

• Strong foundational documentation written and verbal communication and interpersonal skills.

• Basic understanding of statistical techniques and their application in manufacturing or engineering environments.

• Prior experience in Class III medical device manufacturing (preferred).

• Solid understanding of engineering principles theories and concepts relevant to the role.

• Effective problemsolving organizational analytical and criticalthinking skills.

• Working knowledgeof manufacturing processes and equipment used within assigned areas.

• Knowledge of and adherence to Edwards Environmental Health & Safety (EHS) and Quality guidelines particularly within regulated cleanroom medical device manufacturing environments.

• Strong attention to detail and commitment to accuracy.

• Ability to interact professionally and effectively with employees at all organizational levels.

• Ability to manage competing priorities in a fastpaced dynamic environment.

• Proven ability to work collaboratively in a team environment including with supervisors peers crossfunctional partners and external vendors as needed.

• Ability to build and maintain strong stable internal working relationships.

• Commitment to complying with all company policies and requirements including safety environmental quality and health protocols and taking appropriate actions to prevent injury protect the environment and prevent pollution within their scope of influence.

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 (CA) the base pay range for this position is $69000 to $98000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.