Senior Manufacturing Engineer

Company: Edwards Lifesciences
Location: Salt Lake City
Posted on: May 28, 2023

Job Description:

This is an exciting opportunity for a Senior Manufacturing Engineer to join our team and shape the future of our Transcatheter Heart Valve and Transcatheter Mitral and Tricuspid Therapies! This Senior Engineer will be responsible for line support on our Cobra line as it transitions from New Product Development to production and then will support Nexus, the next generation of another device. They will become our laser/tube cutting expert for both areas.Key Responsibilities:

• 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 LeadershipRequired Qualifications:
  • Bachelor's Degree in an Engineering or Scientific field with 4 years of previous related experience required OR
  • Master's Degree or equivalent in an Engineering or Scientific field with 3 years of previous related experience including either industry or industry/education required OR
  • Ph.D. or equivalent in an Engineering or Scientific field with industry experience or industry/education required
  • Experience working in a manufacturing environment required
  • Strong computer skills requiredPreferred Qualifications:
    • Experience working with complex equipment and/or doing design work
    • Proven expertise in usage of MS Office Suite including MS Project; CAD experience
    • Experience working in the medical device industry
    • Experience working with Nitinol
    • Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
    • Basic understanding of statistical techniques
    • Previous experience working with lab/industrial equipment
    • 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 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
    • 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

Keywords: Edwards Lifesciences, Salt Lake City , Senior Manufacturing Engineer, Engineering , Salt Lake City, Utah