Senior Engineer, Product and Process Engineering

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

Job summary

Edwards is seeking a Senior Engineer in Product and Process Engineering to optimize manufacturing processes and ensure equipment and procedures meet high standards. You will design experiments, analyze results, and drive process improvements across manufacturing and compliance functions.

You will collaborate with cross-functional teams, develop training materials, and lead project plans to achieve on-time delivery while adhering to regulatory requirements.

Qualifications

• 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.

Responsibilities

• Identify opportunities to optimize manufacturing processes using Six Sigma and LEAN methods; ensure equipment, tools, fixtures meet standards.
• Develop complex experiments and tests to qualify and validate manufacturing processes; analyze results and develop reports.
• Analyze and resolve complex Manufacturing and Compliance issues (CAPA, non-conformances, audit observations).
• Develop training and documentation materials (work instructions) for production to enable knowledge transfer.
• Lead project plans to ensure deliverables meet customer expectations using project management tools.
• Oversee manufacturing support tasks; train technicians and coordinate technician work.

Skills

Leadership

Communication

Problem solving

Analytical thinking

Project management

FDA regulations

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

PhD in Engineering or Scientific field

Tools

MS Office

MS Project

CAD

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.

The Senior Engineer, for Product and Process Engineering applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

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). Applications will be accepted while this position is posted on our Careers website.