The patients we serve are at the heart of Edwards Lifesciences’ culture. We help our teams achieve this mission by building safe, clean, and innovative workspaces so our people can feel effective with their work. As part of our Facilities team, we’ll provide you with the resources needed to ensure you can keep our offices, plants, and facilities running smoothly so they may be a supportive and dynamic place to work. Your commitment to creating an effective and healthy working environment helps co-workers connect and feel engaged, allowing teams around the world to better contribute and focus their renewed energies on the patients we support.
How you’ll make an impact:
- Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance
- Design, set-up and execute feasibility studies, experiments, and tests - both creating and following established protocols - to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review
- Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time
- Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
- Turn into SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities
- Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents
- Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs)
- Collaborate with Engineering on product/process root cause investigations
- Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval
- Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
- Collaborate with Engineering and CAD/Designers to develop new basic tools
- Provide coaching and guidance to technicians
- Apply in-depth knowledge of processes in the use of machines to ensure successful outcomes, devise complex process changes, and ensure knowledge transfer to other levels of technicians
- Other incidental duties
What you’ll need (Required):
- High School Diploma and Technical or Associate's Degree in industrial maintenance, electromechanical, electrical and/or electronics.
- 4 - 6 years of previous experience in equipment validation, protocol execution and manufacturing equipment maintenance.
- Experience in manufacturing and/or medical device industry or related industries.
- Availability to work Monday to Friday 7:30 a.m. to 5:00 p.m.
- Availability to work in La Lima, Cartago.
- Able to read and comprehend English.
What else we look for (preferred):
- Speaking basic English.
- Strong written and verbal communication, interpersonal, and relationship building skills.
- Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).
- Strong computer skills, including usage of MS Office Suite; and CAD or similar if applicable.
- Full knowledge of validation and improvement of automated equipment.
- Ability to troubleshoot manufacturing equipment.
- Ability to understand the fundamentals of project management.
- Full knowledge of routine preventive maintenance of production equipment.
- Full knowledge electrical, mechanical, electronic, pneumatic, and controls.
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
- Strict attention to detail.
- Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction.