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Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.The
Chief Technology Officer will be key to Pulmotree's continued growth and will work with the CEO to make technology strategy decisions at Pulmotree. The CTO will have full disciplinary responsibility for the entire technical sector of Pulmotree including the development and implementation of product portfolio strategies, will drive Pulmotree's patent portfolio, and will be responsible for the technical project management.
The position has responsibility for all device development activities within Pulmotree for European, US and other global markets and includes the supervision of development projects for new products and oversees all related activities like device design, tool development, component manufacture and device performance testing, spanning all phases from initial device concept through to technology transfer, industrialisation and scaling up to commercial manufacture.
The role forms an important section of the company that drives development projects forward to regulatory submissions and commercialisation. Working closely with internal and external fellows the Chief Technology Officer makes sure at all time, cost, quality, regulatory and commercial manufacturing requirements are met. Through the development of strong relationships, this role will be responsible for ensuring high technical standards and timely delivery.
As a key role of the Pulmotree C-Suite, the individual will contribute to the definition and delivery of company objectives, leading by example and driving improvements in culture and systems.
The Chief Technology Officer ensures the standards of work in the technical departments adhere to relevant GMP, data integrity and other global quality standards, working towards readiness for audits, GMP inspections and FDA pre-approval inspections.
Principal Responsibilities - Management and development of Pulmotree Medical's device development, IP, and technical project management department
- lead and oversee a broad network of external experts who are engaged in the development, industrialisation, scale-up and manufacture of Pulmotree’s devices
- Supervising internal and external development projects from concept to product launch
- Participate as a board member in project steering committees, strategic board meetings and partnering steering committees.
- Develop, implement and effectively maintain Pulmotree Medical’s device development processes according to the requirements of the MDR, ISO 13485:2016, GMP and 21 CFR 820
- Ensures the technical departments own up-to-date knowledge of regulatory and quality guidelines relevant to the device aspects, including design control requirements
- Provide training and support to the Pulmotree organisation or external customers
- Represents Pulmotree Medical to external partners and acts as an entrepreneur with focus on business needs
- Identifies and manages risks throughout the business
- Assist with the analysis and resolution of design or manufacturing problems as these arise during the development process.
- Support technical reliability studies and evaluations of engineering design concepts
- Recommend design or test methods and statistical process control practices for achieving required levels of product reliability
- Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet specifications
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.