About ARTIDIS

　　ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland, that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes.

　　Job Purpose

　　The Head of Production for Medical Devices will be responsible for overseeing and optimizing the entire production process of the ARTIDIS medical devices and consumables. This role will involve strategic leadership, ensuring regulatory compliance, enhancing operational efficiency, and maintaining exceptional quality standards throughout the manufacturing lifecycle.

　　This position requires a visionary and innovative leader capable of blending strategic planning with hands-on operational oversight to ensure the efficient and compliant production of high-quality medical devices.

　　Duties and Responsibilities

　　Develop and execute strategic plans for the production of medical devices in alignment with organizational goals and regulatory standards.

　　Lead, mentor, and manage production teams to ensure efficient workflow, productivity, and adherence to timelines.

　　Setup a production site and all relevant infrastructure for devices and consumables and manage the design transfer from R&D to manufacturing

　　Implement and oversee lean manufacturing principles to develop and optimize processes.

　　Ensure strict adherence to regulatory requirements (Device Master Record, Validation and Risk Management activities as required by FDA, ISO) and quality standards throughout the production process.

　　Collaborate cross-functionally with R&D, Quality Assurance, and Supply Chain teams to drive seamless production processes and product improvements.

　　Manage resources effectively, including budget, equipment, and personnel, to meet production targets and timelines.

　　Identify and mitigate production-related risks, troubleshoot issues, and implement corrective actions as needed.

　　Oversee quality control measures, inspections, and testing procedures to maintain high-quality output and compliance.

　　Generate regular reports on production metrics, performance, and milestones for senior management review.

　　Qualifications

　　Bachelor's degree in Engineering, Manufacturing, or a related field; advanced degree preferred.

　　Minimum of 8-10 years of progressive experience in manufacturing, with at least 5 years in a leadership role within the medical device industry.

　　Profound understanding of FDA, IVDR, MDR and other regulatory requirements pertaining to medical device manufacturing.

　　Strong leadership skills with a proven ability to lead, motivate, and manage teams effectively.

　　Expertise in implementing lean manufacturing principles and continuous improvement methodologies.

　　Experience in maintaining high-quality standards and implementing quality management systems (ISO, GMP).

　　Excellent problem-solving abilities and analytical skills to address complex production challenges.

　　Exceptional communication and interpersonal skills to collaborate effectively across departments.

　　Ability to adapt to a fast-paced environment, manage changing priorities, and drive results under pressure.

　　Working Conditions

　　The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.