2nd Shift Senior Manufacturing Engineer, Metals Processing

Edwards Lifesciences Gruppe; Salt Lake City (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Edwards Lifesciences Gruppe in Salt Lake City, UT, is seeking a Senior Manufacturing Engineer to lead complex improvement initiatives in a highly regulated medical device environment. You will drive yield, capacity, and cost-out projects, mentoring engineers and coordinating with operations, quality, and maintenance teams.

You will apply DOE, SPC, and process validation, develop protocols, support new product transfers, and ensure regulatory compliance.

Qualifications

• Bachelor's degree in engineering or scientific field with 4 years of experience.
• Master's degree or equivalent in engineering or scientific field with 3 years of experience.
• Ph.D. or equivalent in engineering or scientific field with industry or education experience.

Responsibilities

• Lead complex manufacturing improvement initiatives focusing on yield stabilization and capacity expansion.
• Identify and implement opportunities to optimize processes using structured problem solving, Lean, and Six Sigma.
• Serve as technical leader for manufacturing processes, equipment, and technologies.
• Collaborate across Operations, Quality, Supply Chain, Maintenance to improve performance.
• Lead investigations and CAPA, nonconformances, and audit findings to resolve issues.
• Apply data-driven analysis to evaluate process performance and implement corrective actions.
• Support regulatory inspections and internal audits as a technical expert.
• Design experiments, process validations, and equipment qualifications.

Skills

Lean Six Sigma Belt

Statistical analysis

Problem solving

Cross-functional collaboration

Project management

FDA regulatory knowledge

DOE / SPC / process validation

Microsoft Office Suite (Excel, PowerPt

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

Microsoft Office Suite

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 ORMaster's Degree or equivalent in Engineering or Scientific field with 3 years of experience ORPh.D. or equivalent in Engineering or Scientific field with industry or industry/education experienceWhat else we look for (Preferred) :Lean Six Sigma belt certificationAbility 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.