Principal Supplier/Component Quality Engineer, New Product Development job opportunity at Edwards Lifesciences Corporation.

Home Jobs In United States Of America Tag: New Product Development Principal Supplier/Component Quality Engineer, New Product Development position at Edwards Lifesciences Corporation


DateMore Than 30 Days Ago bot
Edwards Lifesciences Corporation Principal Supplier/Component Quality Engineer, New Product Development
Experience: 6-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

New Product Development

Copy Link Report
degreeOND
loacation USA - California – Irvine, United States Of America
loacation USA - Californ..........United States Of America

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 Supplier/Component Supplier Quality Engineer position is a unique career opportunity that could be your next step towards an exciting future. The Principal Supplier/Component 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/Component 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 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.    E dwards 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.

Other Ai Matches

Account Manager TMTT - Hannover/ Magdeburg Applicants are expected to have a solid experience in handling Job related tasks
Territory Manager THV Applicants are expected to have a solid experience in handling Job related tasks
Senior Director, Manufacturing Applicants are expected to have a solid experience in handling Manufacturing related tasks
Senior Director, Program Management, MedTech Applicants are expected to have a solid experience in handling Program Management, MedTech related tasks
Warehouse Clerk Applicants are expected to have a solid experience in handling Job related tasks
Manager, Clinical Training Applicants are expected to have a solid experience in handling Clinical Training related tasks
Senior Quality Systems Analyst Applicants are expected to have a solid experience in handling Job related tasks
Manager, Project Management Applicants are expected to have a solid experience in handling Project Management related tasks
Manufacturing Engineer II Applicants are expected to have a solid experience in handling Job related tasks
Therapy Development Manager (Transcatheter Pulmonary Valve Implants) Applicants are expected to have a solid experience in handling Job related tasks
Senior Territory Manager, Surgical, Mumbai Applicants are expected to have a solid experience in handling Surgical, Mumbai related tasks
Clinical Specialist, THV, 広島 Applicants are expected to have a solid experience in handling THV, 広島 related tasks
Manager, Project Management Applicants are expected to have a solid experience in handling Project Management related tasks
Finance Director, Corporate Giving Applicants are expected to have a solid experience in handling Corporate Giving related tasks
Technologist, Maintenance Applicants are expected to have a solid experience in handling Maintenance related tasks
Senior Director, Exploration Applicants are expected to have a solid experience in handling Exploration related tasks
District Sales Manager, BD Advanced Patient Monitoring Applicants are expected to have a solid experience in handling BD Advanced Patient Monitoring related tasks
Analyst, Quality Systems Applicants are expected to have a solid experience in handling Quality Systems related tasks
Manager, Clinical Contracts and Budgets Applicants are expected to have a solid experience in handling Clinical Contracts and Budgets related tasks
Field Clinical Specialist THV - Southern Italy Applicants are expected to have a solid experience in handling Job related tasks
Field Clinical Specialist, Sapien M3 Applicants are expected to have a solid experience in handling Sapien M3 related tasks
Senior Director, Sales Operations & Commercial Enablement - TMTT Applicants are expected to have a solid experience in handling Sales Operations & Commercial Enablement - TMTT related tasks
Product Manager, Marketing, TMTT Applicants are expected to have a solid experience in handling Marketing, TMTT related tasks