Senior Principal Engineer, New Product Development
Edwards Lifesciences, Irvine, California, United States, 92713
Overview
Innovation starts from the heart. Edwards Lifesciences is a leading global structural heart company focused on improving patient lives. Our Sr. Principal, Engineer, NPD position leads the transition of advanced, sensor-integrated medical devices from design into Commercial production. This role is a key leadership position within the New Product Development (NPD) team, responsible for developing manufacturing processes, test systems, and production specifications that meet global safety and performance standards from Day one. Join the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit to pursue an innovative portfolio of technologies for patients with complex heart valve disease.
What you’ll do (Responsibilities)
Design for Manufacturability (DFM): act as the lead manufacturing voice in R&D design reviews to optimize sensor architectures and electronic assemblies for cost-effective, high-yield production.
Manufacturing Test Strategy: develop and implement end-of-line production testing for safety and functionality, overseeing:
Hipot & Leakage Current Testing: validate production-level insulation and safety under normal and single-fault conditions.
EMC Assurance: ensure manufacturing processes (e.g., cable routing or shielding assembly) do not compromise IEC 60601-1-2 compliance.
Specifications & Drawings: develop detailed manufacturing specifications & Instructions, BOM, and assembly drawings. Partner with R&D to define critical-to-quality (CTQ) dimensions and tolerances for sensors and electronics.
Process Validation (IQ/OQ/PQ): lead the strategy and execution of Installation, Operational, and Performance Qualifications for new assembly lines and automated sensor calibration equipment.
Vendor & Supply Chain Management: interface with external EMS and sensor suppliers to establish quality agreements and technical requirements for sub-assemblies.
Risk Management: author and maintain PFMEA to mitigate risks in the manufacturing of safety-critical electronic systems.
Own device system end to end of new product development; think strategically about new product development.
Lead strategy, prioritization, and technical support for QST, pre-DV, DV – SME to Pilot on root cause investigations for manufacturing processes (prior to commercialization).
Experience developing production-level test fixtures and tooling; hands-on with Hipot testers, leakage current meters, and spectrum analyzers.
Assure drawing review processes and tolerance stack-up compliance.
Drive specifications from an operations perspective (DFx, tolerancing, material selection, automation); establish stability metrics and mitigate risks through SCRR and MRR.
Use voice of the Factory and SME product knowledge to drive improvements and standardization.
Serve as team lead in the analysis of basic Manufacturing and Compliance issues (e.g., CAPA, non-conformance, audit observations) and provide technical support in process transfer.
Identify opportunities for redesign of basic equipment, tools, fixtures, etc., to improve manufacturing processes through all design phases; drive opportunities with R&D and manufacturing (Pilot or Commercial).
Support commercial redesign opportunities and notifications of change from suppliers based on design intent of the device.
Improve manufacturing processes using engineering methods (e.g., LEAN, basic statistics) for continuous process improvement and support stability metrics through design phases.
Follow project plans to ensure deliverables meet customer expectations using project management tools (e.g., Project Plan, Risk Analysis).
Oversee manufacturing support tasks; supervise technicians and/or lower-level engineers.
Perform other incidental duties.
What you’ll need (Required)
Bachelor's Degree in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 8 years of experience in industry or industry/education, or
Master's Degree in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 7 years of experience in industry or industry/education, or
Ph.D. or equivalent in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 4 years of experience in industry or industry/education.
What else we look for (Preferred)
Strong working knowledge of IEC 60601-1 and IEC 60601-2 from a production verification standpoint.
Proficiency in ISO 13485 Quality Management Systems and FDA 21 CFR 820.
Recognized as an expert in own area within the organization with broad-based technical expertise and knowledge of related disciplines.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Strong leadership skills and ability to influence change.
Ability to tackle unusually complex technical problems with innovative and creative solutions.
Interprets internal and external business issues and recommends best practices.
Anticipates potential challenges and proactively seeks novel approaches to resolution.
Guides the successful completion of major programs and may function in a project leadership role.
Contributes to strategic project direction and ensures technologies are up-to-date.
Identifies technical gaps and takes action to address them.
Interacts with senior external representatives on significant technical matters requiring cross-organizational coordination.
Proven expertise in MS Office; CAD experience is preferred.
Excellent documentation and communication skills and strong interpersonal relationships including negotiating and relationship management.
Ability to translate complex technical information to all levels of the organization.
Compensation & Apply Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs. For California, the base pay range is $139,000 to $196,000 (highly experienced). The pay for the successful candidate depends on qualifications, education, and prior experience. Applications will be accepted while this position is posted on our Careers website.
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What you’ll do (Responsibilities)
Design for Manufacturability (DFM): act as the lead manufacturing voice in R&D design reviews to optimize sensor architectures and electronic assemblies for cost-effective, high-yield production.
Manufacturing Test Strategy: develop and implement end-of-line production testing for safety and functionality, overseeing:
Hipot & Leakage Current Testing: validate production-level insulation and safety under normal and single-fault conditions.
EMC Assurance: ensure manufacturing processes (e.g., cable routing or shielding assembly) do not compromise IEC 60601-1-2 compliance.
Specifications & Drawings: develop detailed manufacturing specifications & Instructions, BOM, and assembly drawings. Partner with R&D to define critical-to-quality (CTQ) dimensions and tolerances for sensors and electronics.
Process Validation (IQ/OQ/PQ): lead the strategy and execution of Installation, Operational, and Performance Qualifications for new assembly lines and automated sensor calibration equipment.
Vendor & Supply Chain Management: interface with external EMS and sensor suppliers to establish quality agreements and technical requirements for sub-assemblies.
Risk Management: author and maintain PFMEA to mitigate risks in the manufacturing of safety-critical electronic systems.
Own device system end to end of new product development; think strategically about new product development.
Lead strategy, prioritization, and technical support for QST, pre-DV, DV – SME to Pilot on root cause investigations for manufacturing processes (prior to commercialization).
Experience developing production-level test fixtures and tooling; hands-on with Hipot testers, leakage current meters, and spectrum analyzers.
Assure drawing review processes and tolerance stack-up compliance.
Drive specifications from an operations perspective (DFx, tolerancing, material selection, automation); establish stability metrics and mitigate risks through SCRR and MRR.
Use voice of the Factory and SME product knowledge to drive improvements and standardization.
Serve as team lead in the analysis of basic Manufacturing and Compliance issues (e.g., CAPA, non-conformance, audit observations) and provide technical support in process transfer.
Identify opportunities for redesign of basic equipment, tools, fixtures, etc., to improve manufacturing processes through all design phases; drive opportunities with R&D and manufacturing (Pilot or Commercial).
Support commercial redesign opportunities and notifications of change from suppliers based on design intent of the device.
Improve manufacturing processes using engineering methods (e.g., LEAN, basic statistics) for continuous process improvement and support stability metrics through design phases.
Follow project plans to ensure deliverables meet customer expectations using project management tools (e.g., Project Plan, Risk Analysis).
Oversee manufacturing support tasks; supervise technicians and/or lower-level engineers.
Perform other incidental duties.
What you’ll need (Required)
Bachelor's Degree in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 8 years of experience in industry or industry/education, or
Master's Degree in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 7 years of experience in industry or industry/education, or
Ph.D. or equivalent in Electrical, Manufacturing, or Mechanical Engineering with a minimum of 4 years of experience in industry or industry/education.
What else we look for (Preferred)
Strong working knowledge of IEC 60601-1 and IEC 60601-2 from a production verification standpoint.
Proficiency in ISO 13485 Quality Management Systems and FDA 21 CFR 820.
Recognized as an expert in own area within the organization with broad-based technical expertise and knowledge of related disciplines.
Advanced problem-solving, organizational, analytical and critical thinking skills.
Strong leadership skills and ability to influence change.
Ability to tackle unusually complex technical problems with innovative and creative solutions.
Interprets internal and external business issues and recommends best practices.
Anticipates potential challenges and proactively seeks novel approaches to resolution.
Guides the successful completion of major programs and may function in a project leadership role.
Contributes to strategic project direction and ensures technologies are up-to-date.
Identifies technical gaps and takes action to address them.
Interacts with senior external representatives on significant technical matters requiring cross-organizational coordination.
Proven expertise in MS Office; CAD experience is preferred.
Excellent documentation and communication skills and strong interpersonal relationships including negotiating and relationship management.
Ability to translate complex technical information to all levels of the organization.
Compensation & Apply Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs. For California, the base pay range is $139,000 to $196,000 (highly experienced). The pay for the successful candidate depends on qualifications, education, and prior experience. Applications will be accepted while this position is posted on our Careers website.
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