Edwards Lifesciences Senior Engineer, Steerable Catheters in Salt Lake City, Utah
This is a unique opportunity to join the newly created Steerable Catheter Pilot Engineering Group. This Senior Engineer position will allow someone to get in on the steerable catheter business and implement new manufacturing processes and technology resulting in a high capacity and a sustainable product line. This role will interact with cross-functional internal and external engineering resources to implement advanced processes and have a meaningful and direct impact on new device introduction.
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 customer’s 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
Bachelor's Degree or equivalent in Engineering or Scientific field with 4 years of experience including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education Required
Proven expertise in usage of MS Office Suite including MS Project; CAD experience
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Previous experience working with lab/industrial equipment required
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
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 Braiding process and Equipment
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to manage competing priorities in a fast paced environment
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.