Edwards Lifesciences · 2 hours ago
Principal Manufacturing Engineer, NPD
USA - California – Irvine
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $171K/yr
5+ years expEdwards Lifesciences is a leading company focused on developing groundbreaking medical innovations for structural heart disease. The Principal Manufacturing Engineer will optimize manufacturing processes, lead design control activities, and mentor junior engineers while collaborating closely with R&D and Quality teams to support new product development.
BiotechnologyHealth CareMedicalMedical Device
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 commercialization
Develop and maintain comprehensive manufacturing documentation, including drawings, SOPs, routers, and pFMEAs, across multiple release stages
Oversee drawing review processes and ensure tolerance stack-up 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 SCRR and 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 QST, pre-DV, and DV phases. Partner with Pilot teams to resolve root causes in manufacturing processes prior to 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
Qualification
Required
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
Preferred
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
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase