Chief Technology Officer (CTO)
We seek a dedicated, passionate and hardworking individual who will bring experience, unique perspectives and problem-solving skills to our team. In return, you will be part of a highly skilled EpiGuard team that offers a dynamic and motivational environment and ability to impact our success in the future. We will launch our product in several new markets and expand our product portfolio in the future. If you want to be a part of this journey, please apply to our position.
The person we are seeking will be responsible for the entire lifecycle of all products, solutions, equipment, software and spare parts that EpiGuard delivers to its customers, including technical specifications, manuals, documentation and product quality.
Our CTO will also be:
- Developing technical aspects of the company's strategy to ensure alignment with its business goals.
- Developing company tech roadmap summarizing trends and developments, while also outlining goals for research, design and development
- Furthering the development of existing products and introduction of new products and solutions when mandated by top management.
- Supporting the CEO in decisions regarding all technical IP that is generated through EpiGuard partners and to contribute to maintaining and handling of the patent portfolio.
- Ownership of relevant SOPs, including review of procedures, design documentation and approval, mechanical design, electronic design, software design, verification and validation testing, design change control, design resources and equipment, and overall system design.
- Responsibility for all Design & Development technical agreements and contracts and all documentation related to these.
- Responsibility for all technical documentation such as technical file, device history records, device master records, development plans for software and hardware.
- Organizing the execution of the Product Risk Management tasks throughout the whole Product life cycle.
- Planning, assigning and directing work, while conducting appraisals of employee performance or direct reports.
- Upholding the customer complaint process, coordination of incoming complaints and responsible for nonconformity and customer complaint investigations.
The CTO will be responsible for developing the company's technology strategy, the use of technological resources, and ensuring technologies are used efficiently, profitably, and securely. The role is expected to stay on top of technology trends and developments, while also being responsible for working in compliance with relevant legal, regulatory, ethical and other internal guidelines as set forth in the company Quality Management System (QMS).
The CTO will report directly to the CEO and will be expected to work from our sites in Fredrikstad and Oslo.
- Master's degree in engineering (electrical, computer science or equivalent) or equivalent post degree qualification. Several years of relevant experience may be a substitute in the lack of a formal degree.
- Minimum 5 years of industry experience (Medical devices, software/hardware integration, product development)
- Documented training in relevant standards, especially ISO 13485, ISO 14971
- Knowledge within MDR article 15. is an advantage
- Previous project management experience
- Structured and effective with an analytical and professional approach.
- Excellent interpersonal and communication skills, with the ability to work with a diverse group of individuals and styles, internally (employees) and externally (suppliers and consultants)
- A strong collaborative approach towards stakeholders and enjoy working in cross-functional teams - R&D, quality, clinical, etc.
- You enjoy working in a start-up culture, in the sense that you're adaptable, flexible and have a strong willingness to get the job done
- You have excellent written and verbal communications skills in English
- You respect and adhere to timelines
We can offer varied, exciting and challenging tasks in an innovative start-up company. You will work hands-on with new and life-changing technology, in a role with a lot of responsibility with the ability to make a real difference in the company. Travelling abroad will be required from time to time.
Please reach out to Kristina Skants, Consultant at Kelly Sciences at +47 40 60 73 46 for more information.
EpiGuard is a Norwegian company established in 2015 by a group of doctors at the Oslo University Hospital, together with co-founders Inven2, Eker Group, and Hansen Protection.
The company holds top level expertise with product development and manufacturing. The medical background ranges from intensive care, infectious diseases, internal medicine, and anesthesiology, through to transport medicine.
Our first product is the EpiShuttle, which was developed by clinical experts with first-hand experience in providing advanced treatment and transportation of patients with highly infectious diseases, including Ebola. We aim to continue to develop and manufacture high-end medical equipment for safe transport of contagious patients.
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