Principal Engineer, Supplier Quality at Edwards Lifesciences

Irvine, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Apr, 26

Salary

167000.0

Posted On

11 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Supplier Quality, Manufacturing Engineering, New Product Development, Quality Engineering, Project Management, Statistical Analysis, Risk Assessments, Design Transfer, Supplier Management, Regulatory Compliance, Test Method Validation, Cross-Functional Collaboration, Root Cause Analysis, Inspection Routines, DFM/DFx, Six Sigma

Industry

Medical Equipment Manufacturing

Description

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 discovering lasting solutions for unmet patient needs. Our Principal Engineer, Supplier Quality position is a unique career opportunity that could be your next step towards an exciting future. The Principal Supplier Quality Engineer will play a key role on a critical project within the Transcatheter Heart Valve (THV) business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Marketing, Sourcing, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life-saving medical devices. The Principal Supplier Quality Engineer will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success. How you will make an impact: The Principal Engineer, Supplier Quality will reside in the Transcatheter Heart Valve (THV) Supplier Quality Engineering team to provide quality engineering support in the design and development of implantable device delivery systems to treat cardiovascular disease. Conduct supplier quality engineering activities from the initial product development phase through product launch. Provide technical input for supplier selection, including evaluation of supplier capability, part qualification plan requirements, specification review, product implementation and part transition to manufacturing. Develop and optimize test methods at Receiving Inspection and Supplier (e.g., vision system routines, fixturing design, measurement system analysis, test method SOPs, etc.) to meet new component requirements and product demands and complete test method validations. Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Lead supplier part qualification plan activities, support milestone new product development build component readiness and commercialization of new product introduction. Transfer receiving inspection of new components into manufacturing locations. Conduct drawing reviews to ensure inspection DFX considerations are incorporated into designs. Report test method outputs of component critical features and drive/influence drawing changes where warranted. Participate in technical discussions with suppliers to identify and implement improvements in products and processes. Respond with a high sense of urgency to quality issues and escalate / communicate appropriately. Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner. Perform audits of approved suppliers' quality management system and act as Supplier Quality subject matter expert on cross-functional technical assessments of suppliers that are being considered for addition to the approved supplier list. Lead investigations of supplier component quality and compliance issues. Train, coach, and guide less-senior team members on more complex procedures/requirements. Drive portions of a project, including acting as the project manager for all Supplier Quality tasks in support of the Edwards new product development process and project milestones, and reporting on status of deliverables at cross-functional project forums. Oversee Quality support tasks; provides instruction, training, and feedback to engineers, technicians, and inspectors on component test methods. Perform other duties and responsibilities as assigned. What you’ll need (Required): Bachelor's degree in engineering or scientific field with 6 years of experience in either Supplier Quality, Manufacturing Engineering, New Product Development/Introduction, or Quality Engineering functions; OR a Master's degree in engineering or scientific field with 5 years of experience in either Supplier Quality, Manufacturing Engineering, New Product Development/Introduction, or Quality Engineering functions. Must be willing to work on-site. Ability to travel up to 20% (domestic & international). What else we look for (Preferred): Experience with supplier/vendor management and qualification activities with new suppliers. Experience in medical device, pharmaceutical, or other highly regulated industries (e.g., aerospace, automotive with strong regulatory compliance). Experience in catheter assembly and related sub-assembly components manufacturing technologies in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices. Experience creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks. Strong knowledge of DFM/DFx, component design reviews, and manufacturing capability assessment. Hands-on experience with supplier validations, including IQ/OQ/PQ, process validation, and capability studies. Proven ability to evaluate supplier technical capability, including auditing, risk assessments, and capacity reviews. Experience supporting or leading new product introduction (NPI), design transfer activities, and manufacturing readiness evaluations. Proficiency in statistical analysis and use of quality tools (Six Sigma, DMAIC, DOE, SPC, Gage R&R, pFMEA, dFMEA, etc.). Demonstrated ability to troubleshoot complex quality issues and drive root cause & corrective action (RCCA). Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 risk management. Proven ability to lead cross‑functional deliverables/efforts (R&D, Quality, Manufacturing, Supply Chain, Supplier Management). Strong project management skills, including structuring project milestones. Certifications such as ASQ CQE, CQA, CSSGB/CSSBB, or Six Sigma Black Belt. Proven expertise in usage of 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 (CA), the base pay range for this position is $118,000 to $167,000 (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. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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Responsibilities

The Principal Engineer, Supplier Quality will lead part qualification efforts with external suppliers to support product development and commercial launch timelines for medical devices. This role involves conducting supplier quality engineering activities from initial product development through product launch and managing design transfers to production environments.