Edwards Lifesciences · 2 hours ago
Principal Manufacturing Engineer, NPD
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $171K/yr
5+ years expEdwards Lifesciences is dedicated to innovative medical solutions for structural heart disease. They are seeking a Principal Manufacturing Engineer to lead New Product Development activities, optimize manufacturing processes, and ensure compliance for clinical trials and commercialization.
BiotechnologyHealth CareMedicalMedical Device
Hiring Manager
Megan Mielcarek
Responsibilities
Optimize manufacturing processes by providing expert guidance to improve efficiency, quality, and scalability across operations – leading New Product Development activities for the project
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
Qualification
Required
Bachelor's Degree in Engineering or Scientific field with 6 years experience including either industry or industry/education
Master's Degree or equivalent in Engineering or Scientific field with 5 years experience including either industry or industry/education
Ph.D. or equivalent in Engineering or Scientific field with 2 years experience including either industry or industry/education
Preferred
Strong verbal/written communication and interpersonal skills
Strong project management skills
Basic understanding of statistical techniques required; Six Sigma Black Belt Certification preferred
Previous experience in a manufacturing support role preferred
Strong problem-solving, organizational, analytical and critical thinking skills
Process Validation experience required
Familiarity with Design for Manufacturability and LEAN is preferred
Capable of analyzing and solving complex problems through innovative thought and experience
Ability to manage competing priorities in a fast-paced environment
Ability to work well independently as well as part of a team
Good leadership skills and ability to influence change
Ability to interact professionally with all organizational levels
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
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
Andrew Greene
Vice President, Strategy
Recent News
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2026-01-14
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