Senior Engineer, Continuous Improvement

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.

This Senior Engineer will focus on continuous improvement projects and initiatives at our Draper Utah manufacturing site.

How youll make an impact:

• Identify and ensure 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 customers expectations using project management tools (e.g. Project Plan Risk Analysis etc.)
• 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 youll need (Required):

• Bachelors Degree in an Engineering or Scientific field with 4 years of previous related experience including either industry or industry/education OR
• Masters Degree or equivalent in an Engineering or Scientific field with 3 years of previous related experience including either industry or industry/education OR
• Ph.D. or equivalent in an Engineering or Scientific field with industry experience or industry/education

What else we look for (Preferred):

• Master of Business Administration or Master of Operations
• Experience working in the medical device industry
• Lean Six Sigma Green Belt or Black Belt certification
• Experience with one piece flow line transformation/line balancing
• Proven expertise in usage of MS Office Suite including MS Project
• Strong documentation communication (e.g. written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Substantial understanding and knowledge of principles theories and concepts relevant to Engineering
• Strong problem-solving organizational analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.