Senior Engineer, Electrical Manufacturing

$103,000 - $146,000/Yr

Edwards Lifesciences - Santa Ana, CA

Full-time - Mid Level

Santa Ana, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Electrical Manufacturing Engineer II position at Edwards Lifesciences is a pivotal role within the Critical Care business, which has been at the forefront of medical innovation for over 50 years. As the company transitions to become an independent entity by January 2025, this role will be integral in supporting the development and execution of manufacturing and operations strategies for advanced hemodynamic monitoring systems. The successful candidate will collaborate on various projects and initiatives that are crucial for ongoing manufacturing, new product commercialization, and process improvements. This position is designed for individuals who are passionate about making a meaningful difference in patient care through innovative engineering solutions. In this role, you will be responsible for identifying and implementing opportunities to optimize manufacturing processes using engineering methods such as Six Sigma and LEAN. You will employ your technical design skills to ensure that equipment, tools, and fixtures meet industry standards. Additionally, you will utilize problem-solving skills and data analysis to support production at contract manufacturers, leading initiatives that align with manufacturing goals, including material qualification, supplier changes, and product enhancements. The Electrical Manufacturing Engineer II will also manage change control for ongoing manufacturing changes, ensuring that all modifications are documented and compliant with industry regulations. You will develop complex experiments and tests to validate manufacturing processes, analyze results, and provide recommendations based on your findings. Furthermore, you will create training and documentation materials to facilitate knowledge transfer within the production team, ensuring that all processes are understood and followed. This role requires a proactive approach to project management, utilizing tools such as project plans and risk analysis to ensure that deliverables meet customer expectations. The ideal candidate will thrive in a fast-paced environment, demonstrating strong leadership skills and the ability to influence change across departments. Your work will directly contribute to the mission of improving patient outcomes and enhancing lives through innovative medical technologies.

Responsibilities

• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN).
• Employ technical design skills to redesign/design equipment, tools, fixtures, etc. to meet standards.
• Use technical principles, problem-solving skills, and data analysis to support production at contract manufacturers.
• Lead initiatives to support manufacturing projects and goals, including material qualification, supplier changes, and product enhancements.
• Manage change control for ongoing manufacturing changes, including change requests and product specifications.
• Deploy, review, and act upon meaningful metrics to measure and optimize processes for continuous improvement.
• Develop complex experiments and tests to qualify and validate manufacturing processes; analyze results and make recommendations.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances).
• Develop training and documentation materials for production to enable seamless knowledge transfer.
• Lead and establish project plans to ensure deliverables are completed to customer expectations.

Requirements

• Bachelor's Degree in Engineering or Scientific field with 4 years of experience, or a Master's Degree with 3 years of experience, or a Ph.D. with industry experience.
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred.
• Strong documentation, communication, and interpersonal relationship skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment required.
• Substantial understanding of principles, theories, and concepts relevant to Engineering.
• Strong problem-solving, organizational, analytical, and critical thinking skills.
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines for clean room medical device manufacturing.
• Knowledge of applicable FDA regulations for the medical device industry.
• Ability to interact professionally with all organizational levels and manage competing priorities.

Nice-to-haves

• Lean Champion and/or Six Sigma certifications.
• Ability to use Mechanical CAD tools (Solidworks or ProE).
• Ability to read electronics schematics and mechanical drawings.
• Experience troubleshooting and documenting evaluations of finished devices, sub-assemblies, and component failures.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address diverse individual needs
• COVID-19 vaccination requirement for patient-facing roles