Senior Production Engineer

ppThe Senior Production Engineer is responsible for coordinating, supporting, validating, and monitoring production-related processes to improve quality, efficiency, customer service, and safety, while reducing rejection rates and the cost of goods. This role serves as a key interface between Amber Implants and its manufacturing suppliers. The Senior Production Engineer translates business and technical requirements into efficient and integrated manufacturing processes. The role involves standardizing manufacturing procedures and continuously improving production performance.br/The Senior Production Engineer also monitors and supports the work of manufacturing andbr/quality technicians at supplier facilities, oversees proper documentation and record keeping,br/and prepares reports for quality management. In addition, the role contributes to the evaluationbr/of supplier performance and KPIs.br/As Amber Implants is still in the development and early commercialization phase, product industrialization will be an important part of this role. The Senior Production Engineer will contribute to implementing manufacturing strategies aligned with business objectives and supply chain planning. During New Product Introduction (NPI), the engineer will support the execution of design transfer activities and the release of new products into manufacturing and the supply chain with minimal disruption to ongoing production. /p h3Key Responsibilities /h3 h3Production Coordination /h3 ul liMaintain and control manufacturing documentation, including Device Master Records (DMR), Bills of Materials (BOM), manufacturing plans, work instructions, routings, and inspection procedures, and contribute to the technical review of Device History Records (DHRs) to ensure accuracy, completeness, and compliance with the Quality Management System. /li liAnalyse and map manufacturing processes across the full production chain, from component manufacturing to final assembly, identifying critical steps, bottlenecks, and risks affecting quality, scalability, lead time, and cost. /li liEvaluate and monitor process capability for critical dimensions and characteristics, support implementation of appropriate measurement systems, and contribute to statistical process control (SPC) and quality control methods. /li liSupport the development and maintenance of manufacturing risk registers and contribute to mitigation strategies aimed at improving process robustness and production stability. /li liContribute to the development and monitoring of manufacturing KPIs and support supplier performance management in collaboration with Amber Implants’ manufacturing partners. /li liAssist in product industrialization and new product introduction, including design transfer activities, supplier readiness, and the preparation and control of manufacturing documentation. /li liParticipate in regular technical and operational meetings with manufacturing suppliers, monitoring production performance, addressing deviations, and supporting corrective and preventive actions. /li liImplement and support continuous improvement initiatives to increase manufacturing capacity, improve efficiency, and reduce production costs. /li liCollaborate closely with the Quality Assurance, Design, and Supply Chain teams to ensure manufacturing processes comply with regulatory requirements and quality standards (e.g., ISO 13485, MDR). /li /ul h3Qualifications /h3 ul liUniversity degree in engineering, manufacturing, or a related technical field. /li li4-7 years of experience in manufacturing, NPI, or production engineering environments. /li liProven experience in medical device manufacturing. /li liFluency in English. Italian is considered a plus. /li liStrong communication and presentation skills. /li liAbility to work collaboratively within international and cross-functional teams. /li liExperience with Enterprise Resource Planning (ERP) systems is preferred. /li liFamiliarity with regulatory requirements and quality standards in the medical device industry (ISO 13485). /li liAbility to work effectively in a fast-paced environment and manage multiple projects simultaneously. /li liStrong analytical skills and attention to detail. /li liAbility to work independently and make sound decisions. /li liStrategic thinking and the ability to manage complex projects while maintaining a big-picture perspective. /li liFlexibility to adapt to varying workloads. /li liAbility to work from the office in The Hague. /li /ul pbThe vacancy is for a full-time position (36-40 hours per week). /b /p h3What

We Offer
/h3 ul liThe opportunity to contribute to improving patient care through innovative medical technology. /li liThe opportunity to work in a dynamic and rapidly growing startup with an international market. /li liA stimulating work environment with new challenges every day. /li liPersonal and professional development opportunities. /li liFriday afternoon drinks and regular company events. /li liMult