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Edwards Lifesciences Engineer II, Manufacturing in Anasco All Locs, Puerto Rico

Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

Key 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

• Incidental duties as assigned by leadership

Education and Experience:

Bachelor's Degree or equivalent in in Engineering or Scientific field, 2 years experience. Previous experience working with lab/industrial equipment, required; or

Master's Degree or equivalent, plus internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required

Additional Skills:

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic (UT: Good) understanding of statistical techniques

• Previous experience working with lab/industrial equipment required (if applicable)

• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Solid problem-solving, organizational, analytical and critical thinking skills

• Solid understanding of processes and equipment used in assigned work

• 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 interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Work is performed independently and reviewed upon completion for soundness in technical judgment, overall adequacy and accuracy

• Participates in determining objectives of assignment; arranges own activities in accomplishing objectives

• Contributes to the completion of more complex organizational projects and goals

• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Ability to build productive internal/external working relationships

• Develops solutions to a variety of problems of moderate scope and complexity

• Contributes to process improvements

• Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory requirements.

• Adhere to all EHS rules and requirements 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

• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel

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 13,000 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.

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