Senior Engineer, Manufacturing

Edwards Lifesciences • Salt Lake, UT

5d

About The Position

The Senior Manufacturing Engineer supports Advanced Catheter manufacturing operations through sustaining and production-line support, continuous improvement projects, and yield improvement initiatives. The role partners with cross-functional teams to identify opportunities, resolve manufacturing challenges, and improve process performance. The engineer serves as a technical leader and subject matter expert for manufacturing processes, equipment, and associated technologies, and leads complex improvements in yield, process capability, capacity, cost, and operational risk. The position also supports investigations, regulatory and audit activities, engineering studies, validations, equipment qualifications, and the integration of new products, equipment, and technologies. The engineer leads projects from concept through implementation and provides technical direction, mentoring, training, and documentation to support manufacturing operations and knowledge transfer.

Requirements

• Bachelor's degree in an engineering or scientific field and 4 years of experience; or a master's degree or equivalent in an engineering or scientific field and 3 years of experience; or a Ph.D. or equivalent in an engineering or scientific field with industry or industry/education experience.

Nice To Haves

• Six Sigma Green Belt, Black Belt, or equivalent DMAIC methodology certification.
• PMP certification.
• 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 in an FDA-regulated manufacturing environment, preferably medical device manufacturing.
• 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

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability improvement, capacity expansion, cost reduction, and operational risk mitigation.
• Identify, prioritize, and implement manufacturing process optimization opportunities using structured problem-solving methodologies, statistical analysis, Lean Manufacturing, and continuous improvement principles.
• Serve as a technical leader and subject matter expert for manufacturing processes, equipment, and associated technologies.
• Collaborate with Operations, Quality, Supply Chain, Maintenance, and other cross-functional teams to improve manufacturing performance and achieve business objectives.
• Lead investigations and resolution of complex manufacturing, quality, and compliance issues, including CAPAs, nonconformances, audit observations, process deviations, and customer-impacting events.
• Use data-driven decision-making and statistical techniques to evaluate process performance, identify root causes, and implement corrective and preventive actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a manufacturing technical expert.
• Design and execute engineering studies, experiments, process validations, and equipment qualifications; develop protocols, analyze results, prepare technical reports, and recommend implementation strategies based on data and risk assessment.
• Support introduction and integration of new products, equipment, manufacturing technologies, and process improvements while ensuring compliance, manufacturability, and operational readiness.
• Ensure manufacturing equipment, tooling, fixtures, and processes meet safety, quality, performance, and regulatory requirements.
• Lead cross-functional projects from concept through implementation using project management tools, risk assessments, and structured execution plans.
• Influence engineers, technicians, operations personnel, and business partners to achieve project objectives without direct authority.
• Mentor engineers and technicians in engineering best practices, manufacturing process control, data analysis, and structured problem solving.
• Provide technical direction and training to technicians supporting manufacturing operations and engineering studies.
• Develop and maintain manufacturing documentation, work instructions, procedures, training materials, and engineering records.

What This Job Offers

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