Senior Manufacturing Engineer, New Product Development

Edwards Lifesciences • Irvine, CA

19h • $108,000 - $153,000

About The Position

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue in research and development to create 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 partners to develop the latest tools and technologies that address significant unmet clinical needs for patients around the world. We’re dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We’re working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease. Join us and be part of our inspiring journey. How you'll make an impact Apply technical principles and Edwards systems/procedures to optimize manufacturing processes. Support and drive complex design control activities related to manufacturing products and processes. Develop manufacturing documentation (e.g., drawings, SOPs, routers, pFMEAs) at various release levels, ensuring accuracy of drawing reviews and compliance with tolerance stack-ups. Create advanced training and documentation materials (e.g., work instructions) to enable seamless transfer of knowledge for project and manufacturing processes. Execute and create process definitions and process controls while evaluating new and existing standards. Drive specifications from an operations perspective (e.g., DFx, tolerancing, material selection, automation), establish stability metrics, and mitigate risks through SCRR and MRR. Leverage Voice of the Factory and SME knowledge to drive improvements and standardization. Lead build strategy, prioritization, and technical support for QST, pre-DV, and DV phases, serving as a key partner to Pilot during root-cause investigations related to manufacturing processes prior to commercialization. Develop complex experiments and tests—including writing and executing protocols—to characterize and advance processes. Execute IQ/OQ/software qualifications and validations, and mentor junior engineers through these activities. Collaborate with cross-functional teams on the development of manufacturing equipment, engineering solutions, and tooling design (program-specific). Lead analysis of manufacturing and compliance issues (e.g., CAPA, nonconformance, audit observations) and provide technical support during process transfer. Identify opportunities to design or re-design equipment, tools, fixtures, and related components to improve manufacturing processes. Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) to support continuous improvement activities. Follow project plans and ensure deliverables meet customer expectations using project management tools (e.g., project plans, risk analyses). Perform other incidental duties as assigned by leadership.

Requirements

• Bachelor’s degree in an Engineering or Scientific field and 4 years of experience in industry or a combination of industry and education; or Master’s degree in an Engineering or Scientific field and 3 years of experience in industry or a combination of industry and education; or Ph.D. in an Engineering or Scientific field with relevant industry or industry/education experience.

Nice To Haves

• Demonstrated expertise with the MS Office Suite, including MS Project
• CAD experience preferred (as applicable).
• Strong documentation and communication skills (written and verbal), with excellent interpersonal and consultative relationship-building abilities.
• A foundational understanding of statistical techniques.
• Experience working with lab or industrial equipment (as applicable).
• A solid understanding of engineering principles, theories, and concepts.
• Strong problem-solving, analytical, organizational, and critical-thinking skills.
• Substantial understanding of the processes and equipment used in assigned work.
• Effective leadership skills with the ability to influence change.
• Knowledge of applicable FDA regulations for the medical device industry.
• High 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 cross-functional teams, and to serve as a key contact representing the organization on contracts or projects.
• Commitment to adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and to taking appropriate measures to prevent injury and protect the environment within your span of influence.

Responsibilities

• Apply technical principles and Edwards systems/procedures to optimize manufacturing processes.
• Support and drive complex design control activities related to manufacturing products and processes.
• Develop manufacturing documentation (e.g., drawings, SOPs, routers, pFMEAs) at various release levels, ensuring accuracy of drawing reviews and compliance with tolerance stack-ups.
• Create advanced training and documentation materials (e.g., work instructions) to enable seamless transfer of knowledge for project and manufacturing processes.
• Execute and create process definitions and process controls while evaluating new and existing standards.
• Drive specifications from an operations perspective (e.g., DFx, tolerancing, material selection, automation), establish stability metrics, and mitigate risks through SCRR and MRR.
• Leverage Voice of the Factory and SME knowledge to drive improvements and standardization.
• Lead build strategy, prioritization, and technical support for QST, pre-DV, and DV phases, serving as a key partner to Pilot during root-cause investigations related to manufacturing processes prior to commercialization.
• Develop complex experiments and tests—including writing and executing protocols—to characterize and advance processes.
• Execute IQ/OQ/software qualifications and validations, and mentor junior engineers through these activities.
• Collaborate with cross-functional teams on the development of manufacturing equipment, engineering solutions, and tooling design (program-specific).
• Lead analysis of manufacturing and compliance issues (e.g., CAPA, nonconformance, audit observations) and provide technical support during process transfer.
• Identify opportunities to design or re-design equipment, tools, fixtures, and related components to improve manufacturing processes.
• Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) to support continuous improvement activities.
• Follow project plans and ensure deliverables meet customer expectations using project management tools (e.g., project plans, risk analyses).
• Perform other incidental duties as assigned by leadership.

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: Mid Level