Détails du poste

Responsibilities

·         Head of the injection molding department for medical technology (clean room production), including production planning and control as well as team leadership

·         Development, optimization, and monitoring of injection molding processes (2 components) to produce medical devices made from thermoplastics in clean room conditions

·         Responsibility for the implementation of new tools and materials into serial production

·         Process validations in accordance with ISO 13485 and support in the preparation of qualification and validation documentation (IQ, OQ, PQ)

·         Analysis and resolution of process deviations in close collaboration with Quality Assurance and Production

·         Support during audits (internal/external) and ensuring compliance with regulatory requirements

·         Execution of test series, including evaluation and documentation of results

·         Contribution to continuous improvement initiatives (CIP, Lean)

·         Training of production staff regarding new processes or process changes

Profile:

·         Degree in Plastics Engineering, Mechanical Engineering, Medical Technology, or a comparable qualification

·         Several years of professional experience in thermoplastic injection molding, ideally in the medical technology sector

·         At least 5 years of management experience with employees in a complex production environment

·         Experience in production planning and control in injection molding

·         Experience in two-component (2K) injection molding is desirable

·         Solid knowledge of the DIN EN ISO 13485 standard and experience with processes requiring validation

·         Practical experience in cleanroom production environments

·         Expertise in process analysis and optimization

·         Proficiency in working with CAQ and ERP systems is an advantage

·         Strong quality awareness, structured working style, and team-oriented mindset

·         Willingness to travel (occasionally, within Central Europe)

·         Good command of Romanian and English, both written and spoken