Senior Engineer, Manufacturing

Edwards Lifesciences • Salt Lake, UT

12d

About The Position

The Senior Engineer, Manufacturing supports and sustains the manufacturing of transcatheter heart valve (THV) delivery systems, with a strong emphasis on continuous improvement. The role leads and collaborates with teams to improve manufacturing processes and product quality while ensuring operational efficiency. It focuses heavily on lean manufacturing and continuous improvement.

The engineer identifies and implements process improvements, develops and executes experiments to qualify and validate manufacturing processes, and analyzes and resolves manufacturing and compliance issues. The role also develops production training and documentation, leads project planning, and oversees manufacturing support tasks performed by technicians.

Requirements

• Bachelor's degree in Engineering and at least 4 years of experience, including industry experience or a combination of industry and education; or a master's degree or equivalent in Engineering and at least 3 years of experience, including industry experience or a combination of industry and education; or a Ph.D. or equivalent in Engineering with industry experience or a combination of industry and education.

Nice To Haves

• Lean Six Sigma belt certification.
• PMP certification.
• Experience in the medical device industry or another highly regulated manufacturing environment.
• Experience with root cause analysis (RCA), nonconformance reports (NCRs), and corrective and preventive actions (CAPAs).
• Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
• Ability to work independently and exercise sound engineering judgment.
• Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Project.
• Knowledge of applicable FDA regulations and quality system requirements.
• Experience with CAPA systems, nonconformance investigations, audit support, change control, and risk management processes.
• Experience applying Design of Experiments (DOE), statistical process control (SPC), process capability analysis, and hypothesis testing.
• Experience supporting process validation and equipment qualification activities.
• Experience leading cross-functional manufacturing improvement projects with measurable business impact.
• Experience supporting new product transfers, equipment implementation, or manufacturing technology integration.
• Experience working with complex manufacturing equipment and automated production systems.

Responsibilities

• Identify and lead opportunities to optimize and improve manufacturing processes using engineering methods such as Six Sigma and Lean.
• Use technical design skills to design or redesign equipment, tools, and fixtures and ensure they meet applicable 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, including CAPAs, nonconformances, and audit observations.
• Develop training and documentation materials, such as work instructions, to support knowledge transfer of project and manufacturing processes.
• Lead and establish project plans to ensure deliverables meet customer expectations, using project management tools such as project plans and risk analyses.
• Lead and oversee manufacturing support tasks; instruct technicians on conducting tests, train and provide feedback to technicians, and coordinate their work.
• Perform other incidental duties assigned by leadership.

What This Job Offers

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