
Posted 7 hours ago
Manufacturing Engineer 2 - Assembly
Philips
Requirements
Bachelor’s degree in Engineering, 3+ years relevant experience, Process validation (IQ, OQ, PQ), Project management, PLM and SAP proficiency, Knowledge of ISO 13485 and 21 CFR 820
Skills
ManufacturingISO 13485SAP
About the role
Responsibilities
- Lead and execute validations and qualifications of manufacturing processes to ensure compliance with quality standards.
- Analyze production issues and scrap codes using root cause analysis and tools such as FMEA and CAPA.
- Manage the introduction of new products from development to operations, specifying operational requirements.
- Coordinate daily management meetings, gemba walks, and cross-functional continuous improvement projects.
- Support internal and external audits, technical documentation, NCR reporting, and corrective/preventive actions.
- Provide technical support and training to operators during process implementations and product transfers.
Requirements
- Bachelor’s degree in an Engineering discipline.
- Minimum of 3 years of relevant manufacturing engineering experience.
- Proven experience in process validations and qualifications (IQ, OQ, PQ, etc.).
- Proficiency in PLM and SAP systems.
- Strong project management skills, including the development of Gantt charts.
- Intermediate English language proficiency.
Preferred Qualifications
- Knowledge of ISO 13485 and 21 CFR 820 regulations.
- Experience with CAPA and NCR processes.
- Knowledge of supplier validation processes and raw material introduction documentation.
About the Company
Philips is a global health technology leader dedicated to improving people's health and wellbeing through meaningful innovation. For over 130 years, we have created technologies that support healthcare practitioners and improve lives across various sectors, including Precision Diagnosis, Image Guided Therapy, and Connected Care.
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Philips · Alajuela
