Edwards Lifesciences · 2 hours ago
Senior Principal Engineer, New Product Development
USA - California – Irvine
Full-time
Onsite
Senior Level, Lead/Staff
$139K/yr - $196K/yr
4+ years expEdwards Lifesciences is a leading global structural heart innovation company dedicated to improving patient lives. They are seeking a Senior Principal Engineer in New Product Development to lead the transition of advanced medical devices into commercial production, ensuring they meet global safety and performance standards.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Design for Manufacturability (DFM): Act as the lead manufacturing voice in R&D design reviews, ensuring that sensor architectures and electronic assemblies are optimized for cost-effective, high-yield production
Manufacturing Test Strategy: Develop and implement end-of-line production testing for safety and functionality, specifically overseeing:
Hipot & Leakage Current Testing: Validating production-level insulation and safety under normal and single-fault conditions
EMC Assurance: Ensuring manufacturing processes (such as cable routing or shielding assembly) do not compromise the device’s IEC 60601-1-2 compliance
Specifications & Drawings: Develop detailed manufacturing specifications & Instructions, Bill of Materials (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 electronic manufacturing services (EMS) and sensor suppliers to establish quality agreements and technical requirements for sub-assemblies
Risk Management: Author and maintain Process Failure Mode and Effects Analysis (PFMEA) to mitigate risks in the manufacturing of safety-critical electronic systems
Own device system end to end of new product development; Start thinking 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 experience with Hipot testers, leakage current meters, and spectrum analyzers
Assure drawing review processes and take responsibility for tolerance stack-up compliance
Drive specifications from an operations perspective (i.e., DFx, tolerancing, material selection, automation), define the establishment of stability metrics, and elevate/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/design of basic equipment, tools, fixtures, etc., to improve manufacturing processes through all design phases; drive and execute opportunities in collaboration with R&D and manufacturing organizations (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 methods, basic statistics) for continuous process improvement and support stability metrics through design phases
Follow project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
Oversee manufacturing support tasks; supervise technicians and/or lower-level engineers
Perform other incidental duties
Qualification
Required
Bachelor's Degree Electrical, Manufacturing, or Mechanical Engineering with minimum of 8 years of experience, including either industry or industry/education Required
Master's Degree Electrical, Manufacturing, or Mechanical Engineering with minimum of 7 years of experience, including either industry or industry/education Required
Ph.D. or equivalent Electrical, Manufacturing, or Mechanical Engineering with minimum of 4 years of experience, including either industry or industry/education Required
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 while applying broad-based technical expertise and has full knowledge of other related disciplines
Advanced problem-solving, organizational, analytical and critical thinking skills
Strong leadership skills and ability to influence change
Works on unusually complex technical problems requiring highly 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
Ensures that technologies are up-to-date and looking ahead
Identifies technical gaps and takes action to address them
Interacts with senior external representatives on significant technical matters often requiring coordination between organizations
Proven expertise in usage of MS Office Suite; CAD experience preferred
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate complex and technical information to all levels of the organizations
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
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