Senior Production Engineer

Location: The Hague

The 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.
The Senior Production Engineer also monitors and supports the work of manufacturing and
quality technicians at supplier facilities, oversees proper documentation and record keeping,
and prepares reports for quality management. In addition, the role contributes to the evaluation
of supplier performance and KPIs.
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.

Key Responsibilities
Production Coordination

Maintain 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.

Analyse 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.

Evaluate 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.

Support the development and maintenance of manufacturing risk registers and contribute to mitigation strategies aimed at improving process robustness and production stability.

Contribute to the development and monitoring of manufacturing KPIs and support supplier performance management in collaboration with Amber Implants’ manufacturing partners.

Assist in product industrialization and new product introduction, including design transfer activities, supplier readiness, and the preparation and control of manufacturing documentation.

Participate in regular technical and operational meetings with manufacturing suppliers, monitoring production performance, addressing deviations, and supporting corrective and preventive actions.

Implement and support continuous improvement initiatives to increase manufacturing capacity, improve efficiency, and reduce production costs.

Collaborate 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).

Qualifications

University degree in engineering, manufacturing, or a related technical field.

4-7 years of experience in manufacturing, NPI, or production engineering environments.

Proven experience in medical device manufacturing.

Fluency in English. Italian is considered a plus.

Strong communication and presentation skills.

Ability to work collaboratively within international and cross-functional teams.

Experience with Enterprise Resource Planning (ERP) systems is preferred.

Familiarity with regulatory requirements and quality standards in the medical device industry (ISO 13485).

Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously.

Strong analytical skills and attention to detail.

Ability to work independently and make sound decisions.

Strategic thinking and the ability to manage complex projects while maintaining a big-picture perspective.

Flexibility to adapt to varying workloads.

Ability to work from the office in The Hague.

The vacancy is for a full-time position (36-40 hours per week).

What We Offer

The opportunity to contribute to improving patient care through innovative medical technology.

The opportunity to work in a…