Olympus Winter & Ibe GmbH (OWI) | Chief Technology Officer
Type of employment:
Permanent employment
Function:
Research & Development
Location:
Hamburg
Reference Number:
80209132-17042025
Website:
https://www.olympus-oste.eu
As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Your responsibilities

• Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements)
• Accept design authority following product launch and release into production. Ensure efficient ongoing transition into ongoing production by appropriate provision of a design authority service to operations and quality
• Assessment of Non Conformance Reports (NCRs) and implementation of agreed corrective / preventive actions to maintain regulatory compliance
• 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
• Develop timelines, cost and resource estimates for product changes and appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule
• 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
• To be responsible for contact to internal and external project sponsors with respect to company products to ensure maintenance of product line and communication and buy in of design change implementation where required
• 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
• Ensure a high product and process quality in collaboration with the quality department and all other departments

Your qualification

• Bachelor’s or Master’s degree in Engineering or equivalent professional education / long years of experience
• Many years of experience in a regulated and highly industrial or scientific engineering design environment
• Project experience
• Experience in change management and non conformity handling for medical devices
• Understanding of a wide range of engineering technologies used in design and manufacturing
• Strong problem solving skills
• Understanding interfaces between functions, understanding the needs of others

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 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 inhouse company gym

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.

• Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements)
• Accept design authority following product launch and release into production. Ensure efficient ongoing transition into ongoing production by appropriate provision of a design authority service to operations and quality
• Assessment of Non Conformance Reports (NCRs) and implementation of agreed corrective / preventive actions to maintain regulatory compliance
• 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
• Develop timelines, cost and resource estimates for product changes and appraise management of performance against plan, communicating and reporting progress to project management to maintain and track compliance to project schedule
• 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
• To be responsible for contact to internal and external project sponsors with respect to company products to ensure maintenance of product line and communication and buy in of design change implementation where required
• 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
• Ensure a high product and process quality in collaboration with the quality department and all other department