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 will support Advanced Catheter manufacturing operations through sustaining and production line support, continuous improvement projects, and yield improvement initiatives. This role will partner closely with cross-functional teams to identify opportunities, resolve manufacturing challenges, and improve process performance.
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):
- 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.
- 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.
