The posting
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.
This Senior Engineer will support and sustain the manufacturing of THV delivery systems, with a strong emphasis on continuous improvement. This role involves leading and collaborating with various teams to enhance manufacturing processes, improve product quality, and ensure operational efficiency. Heavy focus will be put on lean manufacturing and continuous improvement.
How you'll make an impact:
- Identify and lead implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards
- Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
- Lead and Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Other incidental duties assigned by Leadership
What you'll need (Required):
- Bachelor's Degree in Engineering with a minimum of 4 years experience including either industry or industry/education OR
- Master's Degree or equivalent in Engineering with a minimum of 3 years experience including either industry or industry/education OR
- Ph.D. or equivalent in Engineering with industry experience or industry/education
What else we look for (Preferred):
- Lean Six Sigma belt certification
- PMP certification
- Experience working in the medical device industry or another highly regulated manufacturing environment
- Experience with Root Cause Analysis (RCA), Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs)
- 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 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.
