Job requirements and application form

The opportunity: Production & Validation Engineer is responsible for supporting and improving manufacturing operations within a regulated medical device environment. This role ensures that production processes are efficient, compliant and capable of consistently delivering high-quality medical products. The Production Engineer works closely with cross-functional teams including Quality, R&D, Regulatory, Maintenance, and Supply Chain. Responsibilities: 1. Manufacturing Process Support • Monitor daily production activities, troubleshoot issues, and provide timely technical support to maintain output and product quality. • Optimize manufacturing processes through root-cause analysis, cycle-time reduction, and waste elimination. • Develop and maintain work instructions and Test Instructions. • Collaborate closely with production and engineering teams Resolve process challenges within production facilities 2. Process Validation & Compliance – • Execute and document qualification/validation activities (IQ/OQ/PQ) per ISO 13485 and FDA 21 CFR 820 requirements. • Lead engineering investigation and Failure Analysis activities in Operation, on component, product or process level 3. Equipment & Tooling management • Validate new equipment, fixtures, and tooling. • Support preventive maintenance programs and collaborate with maintenance to ensure equipment uptime. • Perform equipment capability studies and implement improvements. • Lead engineering activity regarding design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes • Design new Jigs based on improvement recommendations. 4. Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support

• 5 years of experience in the medical devices industry - a must • Good understanding in mechanics- a must • Professional experience with Solidworks • Clean room work experience including process validation • Familiarity with FDA and ISO 13485 medical device regulations. – a must • Familiarity with Design for Manufacturability and Assembly (DFM / DFA) • Good technical, problem-solving, and hands-on skills - must • Education - BSc. Degree in Mechanical or Biotechnology Engineering. • Good analytical skills, self-starter with drive, focus, and initiative. • Language skills: Good English, both written and verbal