Edwards Lifesciences Manufacturing Engineer II, Tissue Operations in Irvine, California

The Manufacturing Engineer II, Tissue Operations will support equipment development, tooling, process development and optimization, manufacturing line support, process transfers and new product commercialization for tissue used for Class III medical devices. You will be responsible for working with our business unit partners to design, order, install, and validate new equipment in order to support business capacity needs, as well as enable future strategic initiatives.

Responsibilities:

  • Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills

  • Develop moderately 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 moderately 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

  • 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

Qualifications:

Required Education/Skills/Experience:

  • A Bachelor's degree inengineering discipline is required; preferably Mechanical, Manufacturing,or Biomedical Engineering.

  • A minimum of 2 years ofexperience working in a regulated manufacturing facility isrequired.

  • Familiarity withtechnologies and processes related to the assembly and manufacture ofheart valves, surgical instruments, stents, catheters, delivery systems,and/or interventional devices is preferred.

  • Goodcomputer skills in usage of MS Office Suite including MS Project; CADexperience preferred (if applicable)

  • Gooddocumentation, communication (e.g., written and verbal) and interpersonalrelationship skills including consultative and relationship managementskills

  • Basicunderstanding of statistical techniques

  • Previousexperience working with lab/industrial equipment required

  • Solidunderstanding and knowledge of principles, theories, and concepts relevantto Engineering

  • Solidproblem-solving, organizational, analytical and critical thinking skills

  • Solidunderstanding of processes and equipment used in assigned work

  • Strictattention to detail

  • Ability tointeract professionally with all organizational levels

  • Ability tomanage competing priorities in a fast paced environment

  • Must be ableto work in a team environment, including the ability to manage vendors andproject stakeholders

  • Ability tobuild productive internal/external working relationships

About Edwards

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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

Title: Manufacturing Engineer II, Tissue Operations Location: USA-USA-California - Irvine Job Number: 011978