Alajuela, Costa Rica
Onsite
Manufacturing Engineer 2
Continuous improvement projects at department level. Represents Operations in multi-disciplinary teams. Introduces new products from Development to Operations. Specifies requirements from Operations
You are responsible for:
Lead and execute validations and qualifications of manufacturing processes, ensuring compliance with quality standards and regulations such as ISO 13485 and 21 CFR 820.
Analyze production issues and scrap codes using troubleshooting methodologies, root cause analysis, and tools such as FMEA and CAPA.
Coordinate and participate in daily management meetings, gemba walks, and cross-functional projects to ensure continuity and continuous improvement of production processes.
Provide support for internal and external audits, as well as technical documentation activities, NCR reporting, and follow-up of corrective and preventive actions.
Train and provide technical support to operators and production personnel during process implementations, product transfers, and continuous improvement initiatives within the plant.
You're the right fit if:
Bachelor’s degree in any Engineering discipline with a minimum of 3 years of relevant experience.
Knowledge of the supplier validation process and documentation related to the introduction of raw materials into systems.
Lead and execute process validations and qualifications (PV, IQ, PC, OQ, PQ, PPQ, TMV).
Experience in project management, development of Gantt charts, and proficiency in PLM and SAP; intermediate English level required.
Experience in CAPA and NCR processes, troubleshooting scrap codes, and knowledge of ISO 13485 and 21 CFR 820 (preferred).
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This role is an onsite role, Schedule: business hours.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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