R&D Sustaining Engineer

Your Responsibilities - Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements) as part of life cycle management (changes, QIS, CAPA etc.) in cooperation with other specialist departments, taking into account medical application requirements and economic requirements. This applies to both in-house and purchased products and assemblies. The particular focus is on the electrical design of the system and its components, taking into account the various subsystems. Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs Evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements Generate, modify and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR), Good Manufacturing Practice (GMP), International Standards Organisation (ISO) and in accordance with company development standards (e.g. PDD, TDP) throughout the product life cycle to ensure the design is fully documented Progress vendor activities in agreement with global sourcing relative to communication of specifications, development schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly Deliver manufacturable designs acceptable to operations by applying design for manufacture principles, implement and communicate feedback from manufacturing engineers, external suppliers and other sources to the R&D engineer Your qualification - Bachelor’s or Master’s degree in Electrical engineering or equivalent professional education 4+ years of professional experience Confident handling of analogue and digital measurement technology (oscilloscope, analysers) Experience with the creation of circuit diagrams and circuit board design Knowledge of the process-orientated development of medical products is desirable Independent and goal-orientated way of working as well as the ability to work in a team and a pioneering spirit Experience in the area of standardization and certification of medical devices (IEC 60601-1, EMC, ISO, EN). Experience in sustaining regulated devices under Design Control (21 CFR 820), ISO13485, ISO14791, MDR and knowledge of applicable regulations Good or better written and spoken English skills Strong collaboration skills with internal and external partners Ability to work effectively in a multicultural environment Your benefits - 30 days of annual leave Up to 60% mobile work possible + flexible work time model with overtime compensation Holiday and Christmas bonuses Corporate benefits discounts for employees Comprehensive company pension scheme and capital-forming benefits Company restaurant with healthy food (subsidized) Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing Various subsidized company sports groups About Olympus At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit www.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA . Further information: Your future inclusive workplace awaits We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.