Head of IT Development (m/f/d)

• From €30.00/hour from the first day
• A secure job in a future-proof industry
• Flexible working hours
• Flat hierarchies and short lines of communication
• Free employee car park
• Holiday and Christmas bonuses

What you can always rely on at persona service:

• €50 per month as a gift for your mobility depending on the position, e.g. for the Germany ticket and
• Bonuses as well as holiday and Christmas bonuses
• Free tutoring for your children on the Ubimaster learning and tutoring platform
• Numerous shopping discounts with well-known brands via our corporate benefits programme
• Excellent personal support and regular feedback meetings
• Multiple further training opportunities

• As Head of IT Development (m/f/d), you will lead a team of 5 to 10 developers:and jointly set the direction for pioneering software solutions in the medical environment
• The management and further development of the IT development department and responsibility for the development and support of innovative software solutions for medical devices are in your hands
• In ensuring and implementing high quality standards, you always keep an eye on compliance with all regulatory requirements and error analysis
• You work closely with major customers and the parent company, quickly analyse quality problems and initiate appropriate corrective measures in the IT area
• You are responsible for the management and coordination of developers, IT specialists and external service providers as well as smooth interface management with production
• Together with suppliers, you meet the strictest specifications and medical standards and shape the further development of the IT infrastructure for the construction and operation of medical devices
• Compliance with all regulatory requirements (e.g. MDR, data protection, data protection, data security).e.g. MDR, data protection), seamless documentation and innovation management in the field of software technology for medical devices are central components of your daily work
• You independently monitor project progress, budget planning and resource management and continuously introduce optimisations

• You have a university degree with a technical focus in electrical engineering, mechanical engineering, medical technology, physics or computer science
• You have proven relevant experience in product development from the concept phase to market launch
• In addition, you have at least 5 years of experience in the development of active medical devices (class IIa, IIb)
• You already have application knowledge in spirometry, respiratory technology or intensive care medicine
• Your experience extends to production processes, production ramp-up and process validation in manufacturing
• You have proven expertise in plastic injection moulding
• You have experience in clinical evaluation, in post-market surveillance and global approval, for example for Canada, LATAM, ASEAN, China or India
• you are confident and proactive in audits and in dealing with FDA inspections
• you have sound knowledge of measurement and control technology and gas/liquid sensor technology
• in the creation of product files (MDR, FDA) and confident handling of design control and document control
• you have extensive application experience in MDR (EU 2017/745) and several years of experience with relevant standards and norms (ISO 13485, ISO 14971, IEC 62304)
• you are fluent in German and English, at least at level C1 in spoken and written
• a valid work permit is a matter of course for you