Medical Device Risk Manager (m/f/d)

Supporting the risk management of medical devices over all life cycle phases. Coordination of the work of interdisciplinary expert teams in identifying, evaluating and minimizing risks Support of technical experts in the development of safe system architectures and joint creation of safety concepts to ensure product safety Creating and maintaining the required risk management documentation in compliance with regulatory requirements such as the EU Medical Products Regulation (MDR) Close coordination with those responsible for the clinical evaluation to prepare sound risk/benefit evaluations Participation in the assessment of complaints as well as identified product and process errors within the process of corrective and preventive measures (CAPA) Support of the Post-Market Surveillance (PMS) including the evaluation of vigilance/trend data and the derivation of appropriate measures

Complete university studies in engineering, natural sciences, medical technology or comparable qualification Good knowledge in the field of medical technology Insufficient professional experience in the field of risk management of medical devices or in other regulated, safety-critical areas (Pharma, Aerospace, etc.) Knowledge of international risk management standards such as ISO 14971 and common risk management methods and tools (e.g. FTA, FMEA, Bow-Tie Analysis) Experiences in quality management systems such as ISO 13485 or FDA QSR/QMSR (21 CFR Part 820) Knowledge in preferably several of the following areas is desirable: medical electrical devices and relevant standards (e.g. IEC 60601-1) usability of medical devices (e.g. IEC 62366-1) Systems Engineering / Requirements Engineering (e.g. Traceability, Interfaces, System Requirements; optionally ISO/IEC/IEEE 15288) Software and system architecture and software life cycle processes / software development (e.g. IEC 62304) Functional safety (e.g. IEC 61508) Information security / Cybersecurity (e.g. IEC 81001-5-1) ophthalmology

Experiences in project management and/or research are advantageous Profile Very good knowledge of German and English in word and writing Very good analytical skills and security in handling data/statistics (e.g. trend analyses) Ability to balanced, fact-based risk/benefit balancing even in the case of uncertainty, target conflicts and different stakeholder perspectives. Target-oriented, independent work Teamability, very good communication and persuasiveness as well as high moderation competence. Excellent quality and responsibility

Possibilities for mobile work to agree the work-life balance Flexible working hours based on trust Attractive location in Heidelberg with access to the main railway station and the motorway Cost subsidy for the job ticket Company bike for private use as part of a bike leasing offer Parking and bicycle cellar Fitness grant for Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club Attractive, performance-oriented remuneration Continuing and continuing training and a digital learning platform Occupational pension Our Benefits Occupational pension: With an attractive and flexible offer, we support you in providing retirement, so that you can look forward to the future. Bikeleasing: Whether you are an e-bike or a city bike – you can purchase your new company bike – also for private use – as part of our bike leasing offer. We support the global CO2 neutrality. Family business: Our corporate culture offers an international environment with a family operating climate in which you can take your skills. Feedback talks: We see a constructive, reciprocal and continuous feedback culture as an important basis for your next development and career steps. It contributes to our open, transparent and trusting corporate culture and thus also represents an entrepreneurial success factor. Continuous learning and continuing training is one of the success factors in the dynamic environment in which we act. We therefore allow you to access our digital learning platform so that you can extend your professional, social, methodical and personal skills at any time. Fresh fruit and free drinks: A weekly fresh fruit delivery and free local drinks offer a good start to the day and provide you with healthy energy. The exchange with your team during the coffee break is also not a contradiction. Keep fit: With our fitness grant for Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club, we want to support your health. The range of gyms, courses and locations gives you a wide range of sports programs. Jobticket: You are traveling by public transport? We are happy to support you with our contribution to the job ticket and also promote ecological thoughts. Jubilare: In order to appreciate our employees, there are individual attentions to company anniversaries as well as pensions to appreciate these special occasions. Modern working conditions: We offer flexible working hours based on trust, 30 days holiday (based on a 5-day week) and additional special days for special occasions. Onboarding Process: For your optimal start at Heidelberg Engineering, we design an individual installation plan for you, so that your successful onboarding is not in the way. Parking Whether by bike, scooter or car – our free parking facilities and a separate bicycle cellar in the underground garage are available for you. Regular employee events: There are always opportunities for us to celebrate joint successes, such as annual summer and winter festivals, team events, or simply afterwork. Top location: Our attractive location in Heidelberg with direct access to the motorway, ÖPNV and Heidelberg Main Station allows you to travel faster and easy. Corporate Benefits: Our free access to our corporate Benefits platform allows us to offer a variety of discounts and over 800 brands for our employees in a variety of categories, such as culture, fashion, food, car, finance, etc. .