2nd Shift Senior Manufacturing Engineer, Metals Processing

Edwards Lifesciences Gruppe; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City, Utah, is seeking a Senior Manufacturing Engineer to lead complex manufacturing improvements in a highly regulated medical device setting. You will influence yield, capacity, and process capability while guiding cross-functional teams.

The role requires strong problem solving, statistics, and DOE skills, along with mentoring engineers and ensuring compliance with quality systems and FDA standards.

Qualifications

• Bachelor’s degree in Engineering or Science required with 4+ years of experience; Master’s with 3+ years; PhD with relevant experience.
• MBA or certification not required but helpful for leadership tasks.
• Experience in FDA-regulated medical device manufacturing is a plus.

Responsibilities

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability, capacity expansion, cost reduction, and operational risk mitigation.
• Identify and implement opportunities to optimize manufacturing processes using structured problem solving, statistical analysis, Lean Manufacturing, and continuous improvement.
• Serve as a technical leader and SME for manufacturing processes, equipment, and technologies.
• Collaborate with cross-functional teams (Operations, Quality, Supply Chain, Maintenance) to improve performance and meet business objectives.
• Lead investigations and resolution of manufacturing, quality, and compliance issues including CAPAs, nonconformances, and audit observations.
• Apply data-driven decisions and DOE, SPC, and risk assessment to improve processes and implement corrective actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a technical expert.
• Design and execute engineering studies, experiments, validations, and equipment qualifications.
• Develop protocols, analyze results, and deliver technical reports with implementation strategies.

Skills

Problem solving

Statistical analysis

Lean Manufacturing

Cross-functional collaboration

Project management

Structured problem solving

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Ph.D. in Engineering or Scientific field

Tools

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

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 Manufacturing Engineer serves as a technical leader within a highly regulated medical device manufacturing environment, driving process improvement, yield optimization, capacity expansion, and operational excellence for critical implantable component manufacturing operations. This role leads complex manufacturing initiatives, provides technical direction to engineers and technicians, and supports the integration of new products, equipment, and technologies. Success requires strong problem-solving and statistical analysis skills, the ability to resolve complex technical challenges, and a proven track record of influencing cross-functional teams to deliver measurable manufacturing improvements.

How you'll make an impact:

• Lead complex manufacturing improvement initiatives focused on yield stabilization, process capability improvement, capacity expansion, cost reduction, and operational risk mitigation.
• Identify, prioritize, and implement opportunities to optimize manufacturing processes 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.
• Apply data-driven decision making and statistical techniques to evaluate process performance, identify root causes, and implement effective corrective and preventive actions.
• Support regulatory inspections, internal audits, and compliance initiatives as a technical expert within the manufacturing organization.
• Design and execute rigorous engineering studies, experiments, process validations, and equipment qualifications.
• Develop and execute 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 to support operational excellence and knowledge transfer.

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 4 years of experience OR
• Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience OR
• Ph.D. or equivalent in Engineering or Scientific field with industry or industry/education experience

What else we look for (Preferred):

• Lean Six Sigma belt certification
• Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
• Proven 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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.