Senior Manufacturing Engineer

Edwards Lifesciences

Irvine, CA

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JOB DETAILS

SALARY

$108,000–$153,000 Per Year

SKILLS

Analysis Skills, Cleanroom, Communication Skills, Continuous Improvement, Detail Oriented, Documentation, Electronics Manufacturing, Environmental Compliance, Environmental Health, FDA Requirements, Healthcare Providers, Implants, Interpersonal Skills, Knowledge Transfer, Laboratory, Leadership, Lean Six Sigma, Manufacturing, Manufacturing Engineering, Manufacturing Equipment, Manufacturing Execution Systems (MES), Manufacturing Management, Manufacturing Operations, Manufacturing Systems, Manufacturing Technology, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Office, Microsoft Project, Multitasking, Operational Support, Patient Care, Pollution Prevention, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Validation, Product Costing, Production Support, Project Management Software, Project Planning, Quality Management, Quality System Requirements (QSR), Regulations, Reporting Skills, Research & Development (R&D), Risk Analysis, Safety/Work Safety, Team Player, Technical/Engineering Design, Test Plan/Schedule, Vaccination, Writing Skills

LOCATION

Irvine, CA

POSTED

30+ days ago

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. Our Senior Manufacturing Engineer position offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence.

Imagine how your ideas and expertise can change a patient’s life. Our Manufacturing Engineering – Pilot team plays a critical role in enabling robust, scalable manufacturing processes prior to full commercialization. In this role, you will partner cross‑functionally 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 you'll make an impact:

The Pilot Manufacturing Engineering team is looking for a passionate and adaptable Senior Manufacturing Engineer to support our dynamic and everchanging 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 processes. In this position, you will:

+ Identify and ensure implementation of 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 execute complex experiments and tests (including authoring 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., 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 establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., project plans, risk analyses).

+ Oversee manufacturing support tasks; instruct technicians on conducting tests; train technicians, provide feedback, and coordinate technician work.

+ Create, test, and validate laser cutting and automated inspection routines for tissue and textile components in support of NPD and R&D teams.

+ Serve as a member of exploration teams evaluating new manufacturing technologies for potential introduction into Pilot Implants/Valves manufacturing.

+ Establish connectivity with manufacturing systems to obtain data and formulate digital solutions that inform engineering improvements in product quality and cost.

+ Create and manage manufacturing workflows and documentation within electronic systems (Manufacturing Execution System – MES).

+ Perform other duties assigned by leadership to support pilot operations and evolving business needs.

What you’ll need (Required):

+ Bachelor’s Degree in Engineering or a related scientific field; 4 years of relevant experience; OR

+ Master’s 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 experience preferred, where applicable.

+ Strong documentation, written and verbal communication, and interpersonal skills, with the ability to build effective consultative relationships with cross‑functional partners.

+ Working knowledge of basic statistical techniques and their application in manufacturing and process validation environments.

+ Previous hands‑on 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 problem‑solving, organizational, analytical, and critical‑thinking 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 clean‑room medical device manufacturing environments.

+ Working knowledge of applicable FDA regulations and 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 fast‑paced, dynamic environment.

+ Ability to work collaboratively in a team‑based, cross‑functional environment and represent the organization on projects or external engagements as needed.

+ Commitment to adhering to all company policies and requirements, including Environmental Health & Safety regulations, injury‑prevention practices, and environmental protection and pollution‑prevention measures within one’s 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 $108,000 to $153,000 (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.

Senior Manufacturing Engineer

Edwards Lifesciences

Irvine, CA

About the Company

Edwards Lifesciences

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