Senior Engineer, Product and Process Engineering

Edwards Lifesciences • Irvine, CA

5d • $108,000 - $153,000

About The Position

The Senior Engineer, Product and Process Engineering applies knowledge of technical principles and Edwards systems and procedures to optimize manufacturing processes. The role contributes to improving manufacturing operations through engineering methods and technical design, process qualification and validation, and resolution of manufacturing and compliance issues. It also develops production training and documentation, leads project plans, and coordinates manufacturing support work with technicians.

Requirements

• Bachelor’s degree in Engineering or a scientific field and 4 years of experience, including industry or industry/education experience; or a Master’s degree or equivalent in Engineering or a scientific field and 3 years of experience, including industry or industry/education experience; or a Ph.D. or equivalent in Engineering or a scientific field with industry or industry/education experience.
• Previous experience working with laboratory or industrial equipment.

Nice To Haves

• Expertise using the MS Office Suite, including MS Project; CAD experience preferred if applicable.
• Strong documentation, written and verbal communication, and interpersonal relationship skills, including consultative and relationship-management skills.
• Basic understanding of statistical techniques.
• Substantial understanding and knowledge of engineering principles, theories, and concepts.
• Strong problem-solving, organizational, analytical, and critical-thinking skills.
• Good leadership skills and ability to influence change.
• Knowledge of applicable FDA regulations for the medical device industry.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work in a team environment, including interdepartmental teams, and to represent the organization as a key contact on contracts or projects.
• Adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and take adequate control measures to prevent injury and pollution and protect the environment.

Responsibilities

• Identify and implement opportunities to optimize and improve manufacturing processes using engineering methods, including Six Sigma and Lean; design or redesign equipment, tools, and fixtures to meet standards.
• Develop complex experiments and tests, including writing and executing protocols, to qualify and validate manufacturing processes; analyze results, make recommendations, and prepare reports.
• Analyze and resolve complex manufacturing and compliance issues, such as CAPAs, non-conformances, and audit observations.
• Develop training and documentation materials, such as work instructions, to support knowledge transfer of project and manufacturing processes to production.
• Lead and establish project plans to ensure deliverables meet customer expectations, using project management tools such as project plans and risk analyses.
• Oversee manufacturing support tasks; instruct technicians on conducting tests, train them, provide feedback, and coordinate their work.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior