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$108k–$153k/yr
Full-time
bachelor degree, postgraduate degree
Competitive salaries, Performance-based incentives, Wide variety of benefits programs
Posted 2d ago
~40 hrs/week
Responsibilities
The Senior Engineer will lead the optimization, validation, and lifecycle support of heart valve manufacturing processes. They will also drive complex process improvement initiatives and manage manufacturing investigations, NCRs, and CAPAs.
Requirements
Candidates must have a Bachelor’s degree in engineering or a scientific field with at least 4 years of manufacturing experience in a highly regulated environment. On-site presence is mandatory to support manufacturing operations and cross-functional collaboration.
Full job description
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
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.
The Senior Engineer will lead the optimization, validation, and lifecycle support of heart valve manufacturing processes across Surgical, Transcatheter Heart Valve (THV), and Transcatheter Mitral & Tricuspid Therapies (TMTT) product lines.
How you’ll make an impact:
Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
Lead complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
Drive manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
Assess manufacturing risks and implement sustainable corrective and preventive actions.
Partner with cross-functional teams, including Operations, Quality, Regulatory, Supply Chain, and R&D, to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes that support product quality, regulatory compliance, operational efficiency, and successful product launches.
What you’ll need:
Bachelor’s degree in engineering or scientific with 4 years of manufacturing experience in a highly regulated environment.
On‑site presence required to effectively collaborate cross‑functionally, and support manufacturing operations.
What else we look for:
Master’s degree; MBA, Mechanical, or Biomedical degree.
Lean or Black Belt certification.
Class III medical device manufacturing experience.
Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
Experience leading scale-up and manufacturing implementation projects.
Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management.
Advanced problem-solving, organizational, analytical, and critical thinking skills.
Proven expertise in MS Office Suite.
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, the base pay range for this position is $108,000 - $153,000 in tool (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.
Related keywords
ManufacturingMedical deviceHeart valveSurgicalTHVTMTTProcess validationIQ/OQ/PQCAPANCRRoot cause analysisDesign for manufacturabilityFDAEH&SLeanBlack Belt
Global leader in the medical device industry with a patient-focused culture of innovation
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Founded
1958
Headquarters
Irvine, CA
LinkedIn followers
429,899
Edwards Lifesciences (NYSE: EW), is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Contact Us
We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus
If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm.
All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
Offices: One Edwards Way, Irvine, CA 92614, US · 12050 S Lone Peak Pkwy, Draper, Utah 84020, US · 1919 Minnesota Crt, Mississauga, Ontario L5N 0C9, CA · Parque Industrial de Itabo, Carr. Sanchez, Km 18.5 Zona Franca Industrial de Haina, Haina, San Cristobal, DO · State Road 402 North, Km 1.4, Industrial Park, Añasco, 00610-1577, PR
Medical DevicesHeart ValvesSurgical MonitoringStructural Heart DiseaseHealth Care TechnologyHeart InnovationsMedical InnovationsHeart Valve TechnologiesHeart Valve TherapiesTranscatheter Mitral &Tricuspid Therapies
Based on 11498 listings with disclosed salaries, most healthcare jobs in California pay between $84k–$228k per year. Individual offers vary with seniority, company size, and specialization.
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