Senior Engineer, Product and Process Engineering

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in California is seeking a skilled engineer to optimize manufacturing processes and lead validation studies. The role requires strong project management, data analysis, and ability to drive improvements across teams in a regulated medical-device environment.

Minimum education includes a engineering/science degree with multiple levels of experience; FDA knowledge is a plus. The position offers competitive pay and comprehensive benefits.

Qualifications

• Bachelor's or higher in engineering/science required.
• Master's or PhD preferred depending on role and experience.
• Experience with lab/industrial equipment is expected.
• Knowledge of FDA regulations for medical devices is a plus.

Responsibilities

• Identify opportunities to optimize manufacturing processes using engineering methods.
• Develop experiments and tests to qualify and validate processes; analyze results and report.
• Resolve manufacturing/compliance issues (CAPAs, non-conformances, audits).
• Create training and work instructions for production to transfer knowledge.
• Lead project plans to meet customer expectations; use project management tools.

Skills

MS Office Suite

MS Project

CAD

Strong communication

Leadership

Statistical techniques

Teamwork

Problem-solving

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent

Ph.D. or equivalent

Tools

CAD software

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross‑functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

How you'll make an impact

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re‑design/design of and ensure equipment, tools, fixtures, etc are up to standards.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non‑conformances, audit observations).
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.

What you'll need (Required)

• Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education.
• Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education.
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education.
• Previous experience working with lab/industrial equipment.

What you'll need (Preferred)

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
• Basic understanding of statistical techniques.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Strong problem-solving, organizational, analytical and critical thinking skills.
• Good leadership skills and ability to influence change.
• Knowledge of applicable FDA regulations for medical device industry.
• Ability to manage competing priorities in a fast paced environment.
• Must be able to work in a team environment, including inter‑departmental teams and key contact representing the organization on contracts or 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.

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.

For California, the base pay range for this position is $108,000 - $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.