Risk-Manager 80 - 100 % (f/m/d)

True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan - our solutions cover a multitude of patient groups, applications and environments.

How you can make a difference:

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post-market, usability, biocompatibility, cybersecurity, vigilance, compliance, etc.

• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes

• Regulatory Compliance & Documentation - Ensure compliance with ISO 14971, ISO13485, MDR 2017/745, 21 CFR 820, IEC 62304, IEC 62366-1, ISO 60601-1, ISO 10993-1/18562, IEC 81001-5-1 or other industry regulations

• Risk Monitoring & Reporting - Maintain risk files, monitor trends, adjust risks, and report findings to management

• Cross-Functional Collaboration - Work with R&D, Quality, Clinical, and Regulatory teams to integrate risk management into operations

• Audits & Training - Support internal and external audits and conduct risk-related training for employees

That's what you bring along:

• Bachelor's or Master's degree in engineering, biomedical engineering, quality management, regulatory affairs, or related field

• At least 2-5 years of experience in risk management, compliance, or quality assurance

• Understanding of risk assessment tools (e.g., FMEA, HAZOP, PHA, FTA) and regulatory requirements

• Strong analytical, communication, and problem solving skills

• Fluent German (at least C1) and English (at least B2) or willingness to learn these independently

Learn more about career opportunities at Hamilton at jobs.hamilton.ch.

Do you share our values and feel at home in a cooperative and down-to-earth environment? At Hamilton, we not only offer a motivating working environment, but also various leisure activities and modern working conditions. Our interactions at eye level encourage open communication and a pleasant working environment. Become part of a team where your skills are valued and innovative ideas are fostered. Interested? Then apply online using the "Apply now" button.If you have any questions, please contact us at jobs@hamilton.ch with the following details:

Reference: JR-4760-fjm/Contact: Aileen Hollmann

Applications by post or e-mail can unfortunately not be considered.