Jobbeschreibung
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.
Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.
- 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 (both in-house and purchased products and assemblies)
- Focus 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
- Evaluate and document 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
- Bachelor's or Master's degree in Electrical Engineering or equivalent professional education
- Several 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 desirable
- 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), ISO 13485, ISO 14791, MDR and knowledge of applicable regulations
- Good command of English, both written and spoken
- Independent and goal-orientated way of working, ability to work in a team as well as pioneering spirit
- Strong skills in collaborating with internal and external partners
- Ability to work effectively in a multicultural environment
- 30 days of annual leave
- Up to 60% mobile work possible and flexible work time model with overtime compensation
- Holiday and Christmas bonuses
- Corporate benefits
- Comprehensive company pension scheme and capital-forming benefits
- Company restaurant with live cooking and 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 and access to the in-house company gym