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Skills: New Product Introduction, Manufacturing Operations, Design Transfer, Process Validation, Equipment Validation
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$108k–$153k/yr
Full-time
bachelor degree
Competitive salaries, Performance-based incentives, Wide variety of benefits programs
Posted 10d ago
~40 hrs/week
Responsibilities
The Senior Engineer leads the commercialization of Class III implantable heart valve products by driving supply chain and manufacturing readiness from development through launch. They partner with cross-functional teams to ensure scalable manufacturing processes, robust validation strategies, and seamless global product delivery.
Requirements
Candidates must hold a bachelor's degree in Mechanical, Manufacturing, or Industrial Engineering and possess at least 4 years of experience in NPI, manufacturing operations, or process validation. The role requires the ability to travel up to 20% and work on-site.
Full job description
Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality (GO&Q) 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.
We’re dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We’re working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey.
The Senior Engineer, New Product Introduction leads the commercialization of Class III implantable THV products, driving supply chain and manufacturing readiness from early development through product launch. This role partners across R&D, Quality, Supplier Development, and Operations to ensure scalable manufacturing processes, supplier preparedness, and seamless global product delivery, supporting successful product launches across the global supply chain network.
How you’ll make an impact:
Support operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness
Partners functionally with pilot, sustaining operations and, domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites. Drive line and capacity expansion plans in manufacturing locations in collaboration with demand planning and commercial groups for uninterrupted product supply.
Lead critical integration meetings to inform stakeholders across GO&Q and related functions on progress and risks. Ensure risks are clearly identified and addressed for smooth execution of development activities
Guide the development of supply chain strategies to attain operational efficiency including assessment of capital and operational expenses to support development needs of the products
Ensure development and implementation of robust characterization and validation activities in collaboration with partners from R&D and quality, including deployment of critical control points in manufacturing
Identify manufacturing and sale-up risks at pilot and production sites, and develop, implement appropriate mitigation plans, including business continuity plans at suppliers. Ensure clear alignment across sites to harmonize actions and site-to-site transfer of knowledge, process and practices as applicable.
Drive continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards
Ensures accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leads the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases.
Ensure design for manufacturability (DFM), Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P across sites. Support MES deployment as needed
Provide analysis and tracks progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.
What you’ll need (Required):
Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field.
A minimum of 4 years of experience in NPI/NPD, manufacturing operations, design transfers, and/or process/equipment validation.
Ability to travel up to 20%, including domestic and international travel.
Onsite position.
What else we look for (Preferred):
Understand injection molding, polymers, medical textiles and commonly used materials in the medical device space, such as Nitinol and implantables, with working knowledge of metals processing.
Experience in developing process requirement specifications, collaborating with external parties, suppliers and working with Operations personnel to establish efficient solution systems
Expertise in the area of manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.
Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
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 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.
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
434,558
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 1207 listings with disclosed salaries, most engineering jobs in Irvine, CA pay between $43k–$187k per year. Individual offers vary with seniority, company size, and specialization.
How many Engineering jobs are open in Irvine, CA right now?
There are currently 1,412 open engineering positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Irvine, CA?
Companies currently hiring include Rivian, mouhamedzz, CoStar Group, Young Community Developers, Edwards Lifesciences, among others. Browse the listings above to see every active employer.
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