Edwards Lifesciences Sr Engineer Material Characterization in Anasco All Locs, Puerto Rico
Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
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 • Train, coach, and guide lower level employees on routine procedures
Education and Experience: Bachelor's Degree in Engineering or Scientific field , 4 years years experience of industry or industry/education related experience Required or Master's Degree or equivalent in Engineering or Scientific field , 3 years years experience of industry or industry/education related experience Required or Ph.D. or equivalent in Engineering or Scientific field no experience Required
Additional Skills: • Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) • Strong 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) • 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 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 adequacy in meeting key objectives • Participates in determining objectives of assignment; plans schedules and arranges own activities in accomplishing objectives • Acts as a resource for colleagues with less experience • Contributes to the completion of significant organizational projects and goals; Input on overall objectives and long-range goals of the organization is given serious consideration • Failure to conclude their piece of a project would have impact causing schedule delay and/or addition of resources • 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 • Develops solutions to a variety of complex problems • Identifies opportunities for 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.