2nd Shift Senior Manufacturing Engineer, Metals Processing

Imagine how your ideas and expertise can change a patients life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. Youll 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 youll 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 youll need (Required):

• Bachelors Degree in Engineering or Scientific field with 4 years of experience OR
• Masters 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.