Principal Engineer, NPD

Edwards Lifesciences • Irvine, CA

9h • $118,000 - $167,000

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Principal, Engineer, NPD position is a unique career opportunity that could be your next step towards an exciting future. Join our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit as a Principal NPD Engineer to boldly pursue an innovative portfolio of technologies for patients with complex heart valve disease. In this exciting New Product Development (NPD) role, you will contribute from Early Human Use through commercialization, developing and optimizing manufacturing processes focused on addressing unmet clinical needs. You will work in high collaboration with R&D, Pilot, and commercial manufacturing teams, joining an inspiring journey to help patients live longer, healthier lives. How you’ll make an impact: Provide expertise in the optimization of manufacturing processes. Drive complex design control activities related to manufacturing products and processes with commercialization in mind. Develop complex documentation related to manufacturing (i.e., drawings, SOP, routers, pFMEA) at various levels of release. Assure drawing review processes and take responsibility for tolerance stack-up compliance. Perform fit testing of design parts and fixtures in alignment with next-level manufacturing expectations (Pilot or Commercial). Develop complex training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes. Execute and create process definitions and develop process controls by evaluating new and existing standards. 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. Identify, define, and implement improvements on designs, optimize processes, and enhance manufacturing ease. Drive line design using TOPP technology. Lead build strategy, prioritization, and technical support for QST, pre-DV, DV; serve as a key partner to Pilot on root cause investigations for manufacturing processes (prior to commercialization). Drive development of complex experiments and tests (including writing and executing protocols) to characterize and develop processes. Drive and/or execute qualifications and validations (IQ, OQ, Software) of manufacturing processes. Lead junior engineers through the process. Lead development of manufacturing equipment engineering and tooling design (Program Specific). 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.

Requirements

• Bachelor’s degree in Engineering or Scientific field with a minimum of 6 years related experience, including either industry or industry/education or Master's Degree or equivalent in Engineering or Scientific field with a minimum of 5 years related experience, including either industry or industry/education or Ph.D. or equivalent in Engineering or Scientific field with minimum of 2 years related experience, including either industry or industry/education

Nice To Haves

• 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 technical information to all levels of the organizations
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific 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

Responsibilities

• Provide expertise in the optimization of manufacturing processes.
• Drive complex design control activities related to manufacturing products and processes with commercialization in mind.
• Develop complex documentation related to manufacturing (i.e., drawings, SOP, routers, pFMEA) at various levels of release.
• Assure drawing review processes and take responsibility for tolerance stack-up compliance.
• Perform fit testing of design parts and fixtures in alignment with next-level manufacturing expectations (Pilot or Commercial).
• Develop complex training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes.
• Execute and create process definitions and develop process controls by evaluating new and existing standards.
• 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.
• Identify, define, and implement improvements on designs, optimize processes, and enhance manufacturing ease.
• Drive line design using TOPP technology.
• Lead build strategy, prioritization, and technical support for QST, pre-DV, DV; serve as a key partner to Pilot on root cause investigations for manufacturing processes (prior to commercialization).
• Drive development of complex experiments and tests (including writing and executing protocols) to characterize and develop processes.
• Drive and/or execute qualifications and validations (IQ, OQ, Software) of manufacturing processes.
• Lead junior engineers through the process.
• Lead development of manufacturing equipment engineering and tooling design (Program Specific).
• 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

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and 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: Principal