Senior Principal Engineer, New Product Development

Edwards Lifesciences • Irvine, CA

2d • $139,000 - $196,000

About The Position

Edwards Lifesciences is seeking a Sr. Principal NPD Engineer to lead the transition of advanced, sensor-integrated medical devices from design into Commercial production. This role is a key leadership position within our New Product Development (NPD) team, responsible for developing the manufacturing processes, test systems, and production specifications that ensure our electronic medical devices meet global safety and performance standards from Day one. The Sr. Principal Engineer will 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. They will develop and implement end-of-line production testing for safety and functionality, including Hipot & Leakage Current Testing and EMC Assurance. The role involves developing detailed manufacturing specifications & Instructions, Bill of Materials (BOM), and assembly drawings, and partnering with R&D to define critical-to-quality (CTQ) dimensions and tolerances for sensors and electronics. Additionally, the Sr. Principal Engineer will lead the strategy and execution of Installation, Operational, and Performance Qualifications for new assembly lines and automated sensor calibration equipment, interface with external electronic manufacturing services (EMS) and sensor suppliers, and author and maintain Process Failure Mode and Effects Analysis (PFMEA). This position owns the device system end-to-end of new product development, thinking strategically about new product development, leading strategy, prioritization, and technical support for QST, pre DV, DV – SME to Pilot on root cause investigations for manufacturing processes (prior to commercialization). They will also serve as team lead in the analysis of basic Manufacturing and Compliance issues and provide technical support in process transfer, identify opportunities for redesign/design of basic equipment, tools, fixtures, etc., and support commercial redesign opportunities and notifications of change from suppliers. The role involves improving manufacturing processes using engineering methods for continuous process improvement and supporting stability metrics through design phases, following project plans to ensure deliverables are completed to customer expectations, and overseeing manufacturing support tasks, supervising technicians and/or lower-level engineers.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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.
• Develop and implement end-of-line production testing for safety and functionality, specifically overseeing: Hipot & Leakage Current Testing and EMC Assurance.
• 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.
• Lead the strategy and execution of Installation, Operational, and Performance Qualifications for new assembly lines and automated sensor calibration equipment.
• Interface with external electronic manufacturing services (EMS) and sensor suppliers to establish quality agreements and technical requirements for sub-assemblies.
• 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.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree