Senior Engineer, Manufacturing

Edwards Lifesciences • Irvine, CA

4d • $108,000 - $153,000

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 delivering lasting solutions for unmet patient needs. Our Senior Manufacturing Engineer position offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence. Imagine how your ideas and expertise can change a patient’s life. Our Manufacturing Engineering – Pilot team plays a critical role in enabling robust, scalable manufacturing processes prior to full commercialization. In this role, you will partner cross‑functionally with Manufacturing, Quality, R&D, and Operations teams to support pilot production, qualify processes and equipment, and drive continuous improvement within a regulated medical device environment.

Requirements

• Bachelor’s Degree in Engineering or a related scientific field; 4 years of relevant experience; OR Master’s Degree or equivalent in Engineering or a related scientific field; 3 years of relevant experience; OR Ph.D. or equivalent in Engineering or a related scientific field with relevant industry and/or academic experience.

Nice To Haves

• Demonstrated proficiency with the MS Office Suite, including MS Project
• CAD experience preferred, where applicable.
• Strong documentation, written and verbal communication, and interpersonal skills, with the ability to build effective consultative relationships with cross‑functional partners.
• Working knowledge of basic statistical techniques and their application in manufacturing and process validation environments.
• Previous hands‑on experience working with lab and/or industrial manufacturing equipment, as applicable.
• Solid understanding of engineering principles, theories, and concepts relevant to manufacturing and pilot operations.
• Strong problem‑solving, organizational, analytical, and critical‑thinking skills, with the ability to evaluate and resolve complex issues.
• Thorough understanding of manufacturing processes and production equipment used within the assigned area.
• Demonstrated leadership capabilities, with the ability to influence change and drive continuous improvement initiatives.
• Knowledge of and compliance with Edwards Environmental Health & Safety (EHS) and Quality System requirements, particularly within clean‑room medical device manufacturing environments.
• Working knowledge of applicable FDA regulations and regulatory expectations for the medical device industry.
• High attention to detail with a strong commitment to accuracy and quality.
• Ability to interact professionally and effectively with employees at all organizational levels, including senior internal and external stakeholders.
• Proven ability to manage multiple competing priorities in a fast‑paced, dynamic environment.
• Ability to work collaboratively in a team‑based, cross‑functional environment and represent the organization on projects or external engagements as needed.
• Commitment to adhering to all company policies and requirements, including Environmental Health & Safety regulations, injury‑prevention practices, and environmental protection and pollution‑prevention measures within one’s area of responsibility.

Responsibilities

• Apply knowledge of technical engineering principles and Edwards systems and procedures to support, optimize, and sustain manufacturing processes within a pilot production environment.
• Identify, recommend, and help implement opportunities to improve manufacturing processes using engineering methods such as Lean and Six Sigma; apply technical design skills to design, redesign, qualify, and ensure equipment, tools, and fixtures meet applicable standards and requirements.
• Develop and execute complex experiments and testing activities, including authoring and executing protocols, to qualify and validate manufacturing processes; analyze results, provide recommendations, and document findings in formal reports.
• Analyze and resolve complex manufacturing and compliance issues, including CAPA, non‑conformances, and audit observations, ensuring timely and effective resolution.
• Develop and maintain training materials and manufacturing documentation (e.g., work instructions and procedures) to enable effective knowledge transfer and consistent execution of pilot and manufacturing processes.
• Lead and manage project plans to ensure deliverables are completed on time and meet customer expectations, utilizing project management tools such as project plans, schedules, and risk analyses.
• Provide hands‑on manufacturing support by overseeing technician activities; instructing and training technicians on test execution and process tasks; providing feedback; and coordinating day-to-day technician work.
• Perform other duties as assigned by leadership to support pilot operations and business needs.

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
• Number of Employees: 5,001-10,000 employees