Manufacturing Engineer

Objective of the jobSupport of the Production Process through a broad spectrum of activities.Tasks & Responsibilities• Production and warehouse assets and equipment management per QMS: o Hand-on calibration and maintenance o 3rd party service suppliers’ management o Equipment updates or introduction assessment and implementation• Engineering change management support o Design changes planning, execution and implementation o Documentation per QMS o Preparation of training material and personnel training• QA RA support o NCMRs, CAPAs engineering related activities support o Audits support• Process and Design improvements and optimization o Support on production process improvements ideation, planning and executionRequested profile• Must: o Bachelor’s or higher degrees in biomedical, mechanical or electrical engineering o Minimum of one-year experience in a highly regulated environment and strict QMS o Express high technical knowledge and troubleshooting capability o Hand-on maintenance experience o Fluent in English, both writing and speaking o Proficiency in Microsoft Office suite o Self-dependent, open minded, eager to learn and team player• Good to have: o Programming capabilities in any language o Experience in medical device standards o Knowledge of EtO sterilization is a plus o Cleanroom working experience is a plus o Capable of lifting 15kg of goods occasionally