Principal Manufacturing Engineer, NPD

Edwards Lifesciences•Irvine, CA

About The Position

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Optimize manufacturing processes by providing expert guidance to improve efficiency, quality, and scalability across operations. Lead design control activities for products and processes, ensuring readiness for clinical trials and commercialization. Develop and maintain comprehensive manufacturing documentation, including drawings, SOPs, routers, and pFMEAs, across multiple release stages. Oversee Participate in drawing review processes and ensure tolerance stack-up analysis to ensure compliance to meet quality standards. Conduct fit testing of design parts and fixtures to align with pilot and commercial manufacturing expectations. Create detailed training materials and work instructions to support production teams and enable smooth knowledge transfer. Define processes, implement robust process controls, and evaluate new and existing standards for continuous improvement. Influence specifications from an operations perspective (DFx, tolerancing, material selection, automation), establish stability metrics, and mitigate risks through Supply Chain Readiness Review (SCRR) and Manufacturing Readiness Review (MRR) processes. Leverage factory insights and SME knowledge to drive standardization and improvements. Identify and implement design enhancements to optimize manufacturability and ease of production. Utilize TOPP technology to design efficient production lines. Lead build strategies, prioritize activities, and provide technical support for Quality System Testing (QST), pre-DV, and DV phases. Partner with Pilot, R&D, and Quality teams to resolve root causes in manufacturing processes prior to clinical and commercial builds commercialization. Design and execute complex experiments and protocols to characterize and refine processes. Lead qualifications and validations (IQ, OQ, software) for manufacturing systems. Mentor junior engineers through process development and execution. Lead the design and development of manufacturing equipment and tooling for program-specific needs. Analyze manufacturing and compliance issues (CAPA, non-conformance, audit observations) and provide technical support for process transfers. Identify opportunities to redesign or improve equipment, tools, and fixtures across all design phases. Collaborate with R&D and manufacturing teams to implement improvements for pilot and commercial production. Manage redesign opportunities and supplier-driven changes to ensure alignment with device design intent. Apply engineering methods (e.g., LEAN principles, basic statistics) to improve manufacturing processes and support stability metrics throughout design phases. Follow project plans to ensure deliverables meet customer expectations, using project management tools such as project plans and risk analysis. Oversee manufacturing support tasks and supervise technicians and junior engineers. Perform other incidental duties as assigned.

Requirements

Bachelor's Degree in Engineering or Scientific field with 6 years experience including either industry or industry/education (or) Master's Degree or equivalent in Engineering or Scientific field with 5 years experience including either industry or industry/education (or) Ph.D. or equivalent in Engineering or Scientific field with 2 years experience including either industry or industry/education

Nice To Haves

Demonstrated proficiency with the Microsoft Office Suite; CAD experience strongly preferred
Exceptional documentation, communication, and interpersonal skills, including negotiation and relationship‑management capabilities
Ability to clearly translate complex technical information for audiences at all organizational levels
Deep knowledge of engineering principles, theories, and concepts
Advanced problem‑solving, organizational, analytical, and critical‑thinking abilities
Strong understanding of processes, equipment, and methodologies relevant to assigned work
Proven leadership skills with the ability to influence and drive change
Familiarity with, and adherence to, Edwards Environmental Health & Safety and Quality guidelines, particularly those related to clean‑room medical device manufacturing
Meticulous attention to detail
Ability to collaborate effectively and professionally across all levels of the organization
Skilled at managing multiple competing priorities in a fast‑paced environment
Ability to thrive in a team‑oriented setting, including frequent cross‑functional and external customer interactions
Represents the organization effectively by providing solutions to complex technical challenges within assigned projects
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Responsibilities

Optimize manufacturing processes by providing expert guidance to improve efficiency, quality, and scalability across operations.
Lead design control activities for products and processes, ensuring readiness for clinical trials and commercialization.
Develop and maintain comprehensive manufacturing documentation, including drawings, SOPs, routers, and pFMEAs, across multiple release stages.
Oversee Participate in drawing review processes and ensure tolerance stack-up analysis to ensure compliance to meet quality standards.
Conduct fit testing of design parts and fixtures to align with pilot and commercial manufacturing expectations.
Create detailed training materials and work instructions to support production teams and enable smooth knowledge transfer.
Define processes, implement robust process controls, and evaluate new and existing standards for continuous improvement.
Influence specifications from an operations perspective (DFx, tolerancing, material selection, automation), establish stability metrics, and mitigate risks through Supply Chain Readiness Review (SCRR) and Manufacturing Readiness Review (MRR) processes.
Leverage factory insights and SME knowledge to drive standardization and improvements.
Identify and implement design enhancements to optimize manufacturability and ease of production.
Utilize TOPP technology to design efficient production lines.
Lead build strategies, prioritize activities, and provide technical support for Quality System Testing (QST), pre-DV, and DV phases.
Partner with Pilot, R&D, and Quality teams to resolve root causes in manufacturing processes prior to clinical and commercial builds commercialization.
Design and execute complex experiments and protocols to characterize and refine processes.
Lead qualifications and validations (IQ, OQ, software) for manufacturing systems.
Mentor junior engineers through process development and execution.
Lead the design and development of manufacturing equipment and tooling for program-specific needs.
Analyze manufacturing and compliance issues (CAPA, non-conformance, audit observations) and provide technical support for process transfers.
Identify opportunities to redesign or improve equipment, tools, and fixtures across all design phases.
Collaborate with R&D and manufacturing teams to implement improvements for pilot and commercial production.
Manage redesign opportunities and supplier-driven changes to ensure alignment with device design intent.
Apply engineering methods (e.g., LEAN principles, basic statistics) to improve manufacturing processes and support stability metrics throughout design phases.
Follow project plans to ensure deliverables meet customer expectations, using project management tools such as project plans and risk analysis.
Oversee manufacturing support tasks and supervise technicians and junior engineers.
Perform other incidental duties as assigned.