Principal Engineer, NPD

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences is seeking a New Product Development Engineer to optimize manufacturing processes and drive design control activities for medical devices aimed at commercialization. You will work with R&D and Quality teams to develop documentation, SOPs, and process validations, translating engineering concepts into reliable production outcomes.

Required are a Bachelor's in Engineering or related field with 6+ years of applicable experience, or a higher degree with fewer years.

Qualifications

• Bachelor's degree in Engineering or a Scientific field is required, with 6+ years of related experience.
• Master's degree requires 5+ years; PhD requires at least 2 years of related experience.
• Experience with design control, CAPA, and DFx is preferred.

Responsibilities

• Provide expertise in optimization of manufacturing processes and design control for products and processes.
• Develop complex manufacturing documentation (drawings, SOPs, routers, pFMEA) and review drawings.
• Lead root cause investigations and support process transfer to production.
• Drive process development and qualification efforts (IQ/OQ/Software) and equipment tooling design.

Skills

LEAN principles

Statistical analysis

Document control

Leadership

Problem solving

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

PhD in Engineering or related field

Tools

CAD

MS Office

Job description

At Edwards, we put patients first. We invest a significant proportion of our revenue in research and development to drive groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies that address significant, unmet clinical needs impacting patients' lives around the world.Aortic stenosis affects millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic valve replacement (TAVR) pioneered an innovative, life-changing solution that offers heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It is our driving force to help patients live longer, healthier lives. Join us and be part of our inspiring journey.How you'll make an impact:Provide expertise in the optimization of manufacturing processes and drive complex design control activities for products and processes with commercialization in mind.Develop complex manufacturing documentation (drawings, SOPs, routers, pFMEA) at various levels of release; own drawing review processes and tolerance stack-up compliance.Perform fit testing of design parts and fixtures in alignment with next-level manufacturing expectations (Pilot or Commercial).Create complex training and documentation materials (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.Execute and create process definitions and develop process controls, evaluating new and existing standards.Drive specifications from an operations perspective (DFx, tolerancing, material selection, automation), establish stability metrics, and elevate or mitigate risks through SCRR and MRR; use Voice of the Factory and SME product knowledge to drive improvements and standardization.Identify, define, and implement design improvements that optimize processes and manufacturing ease, including line design using TOPP technology.Lead build strategy, prioritization, and technical support for QST, pre-DV, and DV, serving as a key partner to Pilot on root cause investigations for manufacturing processes prior to commercialization.Drive development and execution of complex experiments and tests (including writing and executing protocols) to characterize and develop processes; execute qualifications and validations (IQ, OQ, Software) of manufacturing processes and lead lower-level engineers through the process.Lead development of manufacturing equipment engineering and tooling design (program specific).Serve as team lead in the analysis of manufacturing and compliance issues (e.g., CAPA, non-conformance, audit observations) and provide technical support in process transfer.Identify and execute opportunities to redesign equipment, tools, and fixtures to improve manufacturing processes across all design phases, in collaboration with R&D and manufacturing (Pilot or Commercial).Support commercial redesign opportunities and supplier notifications of change based on the design intent of the device.Improve manufacturing processes using engineering methods (e.g., LEAN, basic statistics) for continuous 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 and supervise technicians and/or lower-level engineers.Other incidental duties.What you'll need (Required):Bachelor's degree in Engineering or a Scientific field and 6 years of related experience, including either industry or industry/education; ORMaster's degree or equivalent in Engineering or a Scientific field and 5 years of related experience, including either industry or industry/education; ORPh.D. or equivalent in Engineering or a Scientific field and a minimum of 2 years of related experience, including either industry or industry/education.What else we look for (Preferred):Proven expertise using the MS Office Suite; CAD experience preferred.Excellent documentation, communication, and interpersonal skills, including negotiation and relationship management.Ability to translate technical information to all levels of the organization.Extensive knowledge of engineering principles, theories, and concepts.Advanced problem-solving, organizational, analytical, and critical-thinking skills.Strong understanding of the processes and equipment used in assigned work.Demonstrated leadership skills with the ability to influence change.Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines, particularly those related to cleanroom 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.Ability to work effectively in team settings, including frequent inter-organizational and external customer interactions.Ability to represent the organization by providing solutions to complex 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/controlAligning 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.For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.