Manufacturing Engineer 2 – Assembly

About the role

The Manufacturing Engineer 2 – Assembly will drive continuous improvement and support the introduction of new products from development to operations. Working within multidisciplinary teams, you will ensure manufacturing processes meet strict quality and regulatory standards.

Key responsibilities

• Lead and execute validation and qualification of manufacturing processes (PV, IQ, PC, OQ, PQ, PPQ, TMV) ensuring compliance with ISO 13485 and 21 CFR 820.
• Analyze production issues and scrap codes using root‑cause analysis, FMEA and CAPA methodologies.
• Coordinate daily management meetings, gemba walks and cross‑functional projects to sustain process continuity and improvement.
• Support internal and external audits, prepare technical documentation, report NCRs and follow up corrective and preventive actions.
• Train operators and production personnel during process implementations, product transfers and continuous‑improvement initiatives.
• Represent Operations in multidisciplinary teams and act as the liaison for supplier validation and raw‑material introduction.

Required profile

• Bachelor’s degree in an engineering discipline.
• Minimum three years of relevant manufacturing engineering experience.
• Experience with project management, Gantt‑chart development and use of PLM and SAP systems.
• Intermediate level of English.
• Familiarity with ISO 13485 and 21 CFR 820 (preferred).

Required skills

• Process validation and qualification (PV, IQ, PC, OQ, PQ, PPQ, TMV).
• Root‑cause analysis, FMEA, CAPA, NCR handling.
• Supplier validation procedures.
• Use of PLM and SAP software.
• Project management tools and Gantt‑chart creation.
• Knowledge of ISO 13485 and 21 CFR 820 standards.