Principal New Product Development Quality Engineer (THV Quality - Onsite)
Edwards Lifesciences LLC
Application
Details
Posted: 21-Mar-22
Location: Irvine, California
Type: Full Time
Categories:
Quality
Quality Engineering
Internal Number: Req-13196
This Principal New Product Development Quality Engineer will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. This engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.
Key Responsibilities:
Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including those for design verification, validation, and specification development.
Provide quality engineering expertise for new product development programs in the areas of Risk Management, Design Control, Usability Engineering, Statistical Techniques, and Regulatory Compliance as needed.
Collaborate with R&D to develop design requirements and support design freeze, design verification and validation testing
Lead test method development and validation activities for new designs
Lead failure investigations for product failures in design testing and clinical use
Develop and implement inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
Performs other quality-related duties as assigned by management
Required Qualifications:
Bachelor’s Degree in Engineering or Scientific field with a minimum of six (6) years of combined experience in Quality Engineering, R&D, and/or Manufacturing; OR a Master’s Degree in Engineering or Scientific field with a minimum of three (5) years of combined experience in Quality Engineering, R&D, and/or Manufacturing; OR PhD with 2 years of combined experience in Quality Engineering, R&D, and/or Manufacturing.
Knowledge of and experience with new product development, design controls, and/or risk management/usability engineering within medical device industry or other regulated industries
Preferred Qualifications:
Medical device industry experience
Quality Engineering experience in New Product Development from initial concept to commercialization.
Hands-on experience with Design Assurance, including Design Controls, Design Verification & Validation, and Design Test Method Development
Class III new product development experience
Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
Ability to prioritize, plan, and evaluate deliverables to established strategic goals
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
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 13,000 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.
