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USA - California – Irvine, United States of America
Onsite
Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.
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.
How you'll make an impact:
Provide technical ownership for successful development of manufacturing technologies (processes) to seamlessly transition from Early Human Use (EHU) through all phases of Edwards’ Product Development Process (PDP) to meet the manufacturing and supply chain needs of the Business Unit.
Champion design for manufacturability, design and process excellence, six sigma thinking, LEAN, cGMP, EH&S requirements in executing process validations.
Drive resource maximization while minimizing development expenditure.
Work in close collaboration with cross functional partners and peers from Pilot Ops and extended GSC functions such as sourcing, supplier development, supplier quality etc., BU functions such as R&D, PMO, Design Assurance (DA), Regulatory, to align on goals and drive action to meet commitments to the BU including product builds for R&D evaluation, clinical studies, and downstream needs as assigned.
Identify risks across manufacturing operations including those associated with or arising from technology, materials, skills/competencies, design requirements etc. and develop/implement mitigations to deliver successful outcomes for the business.
Lead the development and implementation of tools/methodologies for effective problem-solving, failure analysis, root cause investigation and best practices for agile deployment of responses and robust solutions that deliver superior results that also elevate learning, critical thinking, and impact across the business.
Drive build strategy, prioritization, and technical support for QST, pre DV, DV, OQ and PQ – Key Partner to Pilot on root cause investigations for manufacturing processes.
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 (CCPs) in manufacturing.
Prioritize the timely development of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
Oversee the design and development of manufacturing tools, fixtures and equipment that provide the highest levels of quality and mistake proofing while meeting or exceeding requirements for reliability and robustness that meet Edwards' standards for tools and fixtures including EH&S and ergonomic standards.
What you’ll need (Required):
Bachelor’s Degree in Engineering or Scientific field with 6 years of previously related industry experience OR
Master’s Degree in Engineering or Scientific field with 5 years of previously related industry experience OR
Ph.D. in Engineering or Scientific Field with 2 years of previous related industry experience
What else we look for (Preferred):
Deep expertise in conceptualizing, designing, developing and successful implementation of manufacturing technologies for the assembly of complex devices.
Comfort with CAD package and self-reliant on CAD usage for medium to high-complexity designs including GD&T principles. Ability to review and trouble shoot engineering/component and assembly drawings, assess tolerancing and stack-ups, and application of industry standards such as ISO.
Track record with developing highly capable, reliable and scalable technologies that are agile.
Experience transferring manufacturing lines across sites/geographies and preparing tech transfer knowledge kit.
Knowledge of design controls for Class II & III medical devices, including familiarity with: catheter-based delivery system. implantable devices - NiTi, CoCr, and mechanical devices, polymeric materials, textiles, fabrics, etc. and associated technologies to inspect, join, attach, fabricate and integrate dissimilar materials.
Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage expectations.
Experience in preparing for and presenting project status to leadership, including the development, and managing of dashboards.
Sound understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines.
Ability to influence cross-functional partners, business units, and/or sites and interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
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 $121,000 to $171,000 (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.