Manufacturing Engineer 2 – Molding

About the role

We are looking for a Manufacturing Engineer 2 specialized in molding to drive continuous improvement, support product introductions, and ensure compliance with medical device quality standards.

Key responsibilities

• Lead and execute validations and qualifications of manufacturing processes (PV, IQ, PC, OQ, PQ, PPQ, TMV) while ensuring compliance with ISO 13485 and 21 CFR 820.
• Analyze production issues and scrap codes using troubleshooting, root‑cause analysis, FMEA and CAPA.
• Coordinate daily management meetings, gemba walks, and cross‑functional projects to sustain and improve production processes.
• Provide support for internal and external audits, technical documentation, NCR reporting and follow‑up of corrective and preventive actions.
• Train and support operators and production personnel during process implementations, product transfers and continuous‑improvement initiatives.
• Represent Operations in multidisciplinary teams, introduce new products from Development to Operations and specify operational requirements.

Required profile

• Bachelor’s degree in any engineering discipline.
• Minimum 3 years of relevant experience.
• Knowledge of injection molding (LSR or TP) and process validation methods.
• Experience in project management, Gantt‑chart development, and proficiency with PLM and SAP.
• Intermediate English proficiency.
• Familiarity with CAPA, NCR processes, ISO 13485 and 21 CFR 820 (preferred).

Required skills

• Injection molding (LSR, TP)
• Process validation (PV, IQ, PC, OQ, PQ, PPQ, TMV)
• FMEA
• CAPA
• Root‑cause analysis
• ISO 13485
• 21 CFR 820
• PLM
• SAP
• Gantt‑chart creation
• Project management
• Scrap‑code troubleshooting
• NCR reporting