Senior 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. OurSenior Manufacturing Engineerposition 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:

The Pilot Manufacturing Engineering team is looking for a passionate and adaptable Senior Manufacturing Engineer to support our dynamic andeverchanging Pilot Operations environment in the tissue and textile components area. We are specifically in search of a key contributor for our laser cutting and automated inspection routine this position you will:

• Identify and ensure implementationof opportunities to optimize and improve manufacturing processes including applying engineering methods (e.g. Six Sigma and LEAN) and using technical design skills to design or redesign equipment tools and fixtures to meet standards.

• Develop and executecomplex experiments and tests (including authoring and executing protocols) to qualify and validate manufacturing processes; analyze results make recommendations and develop reports.

• Analyze and resolvecomplex Manufacturing and Compliance issues (e.g. CAPAs non-conformances audit observations).

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

• Lead and establishproject plans to ensure deliverables are completed to customer expectations using project management tools (e.g. project plans risk analyses).

• Overseemanufacturing support tasks; instruct technicians on conducting tests; train technicians provide feedback and coordinate technician work.

• Create test and validatelaser cutting and automated inspection routines for tissue and textile components in support of NPD and R&D teams.

• Serveas a member of exploration teams evaluating new manufacturing technologies for potential introduction into Pilot Implants/Valves manufacturing.

• Establishconnectivity with manufacturing systems to obtain data and formulate digital solutions that inform engineering improvements in product quality and cost.

• Create and managemanufacturing workflows and documentation within electronic systems (Manufacturing Execution System MES).

• Performother duties assigned by leadership to support pilot operations and evolving business needs.

What youll need (Required):

• Bachelors Degree in Engineering or a related scientific field; 4 years of relevant experience; OR

• Masters Degree or equivalent in Engineering or a related scientific field; 3 years of relevant experience; OR

• Ph.D. or equivalent in Engineering or a related scientific field with relevant industry and/or academic experience.

What else we look for (Preferred):

• Demonstrated proficiency with the MS Office Suite including MS Project; CAD experiencepreferred where applicable.

• Strong documentation written and verbal communication and interpersonal skills with the ability to build effective consultative relationships with crossfunctional partners.

• Workingknowledge of basic statistical techniquesand their application in manufacturing and process validation environments.

• Previous handson experience working with lab and/or industrial manufacturing equipment as applicable.

• Solid understanding of engineering principles theories and concepts relevant to manufacturing and pilot operations.

• Strong problemsolving organizational analytical and criticalthinking skills with the ability to evaluate and resolve complex issues.

• Thorough understanding of manufacturing processes and production equipment used within the assigned area.

• Demonstrated leadership capabilities with the ability to influence change and drive continuous improvement initiatives.

• Knowledge of and compliance with Edwards Environmental Health & Safety (EHS)and Quality System requirements particularly within cleanroom medical device manufacturing environments.

• Working knowledge of applicable FDA regulationsand regulatory expectations for the medical device industry.

• High attention to detail with a strong commitment to accuracy and quality.

• Ability to interact professionally and effectively with employees at all organizational levels including senior internal and external stakeholders.

• Proven ability to manage multiple competing priorities in a fastpaced dynamic environment.

• Ability to work collaboratively in a teambased crossfunctional environmentand represent the organization on projects or external engagements as needed.

• Commitment to adhering to all company policies and requirements including Environmental Health & Safety regulations injuryprevention practices and environmental protection and pollutionprevention measures within ones area of responsibility.

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 $108000 to $153000 (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.