CareDx, headquartered in Brisbane, California is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients. The company is focused on pre-transplant diagnostics through the Olerup brand and on post-transplant surveillance through CLIA service testing (Brisbane, CA, US).
Our pre-transplant operations are directed from the Olerup SSP AB office in Stockholm, Sweden, which is also our main production site, with 44 employees. Olerup has a well-established Quality Management System based on ISO 13485. The US and Stockholm organizations share best practices and collaborate on projects.
Currently, we are looking for a Software Development Manager based in our Stockholm office. This position will headup our software development efforts, both for an existing product as well as future products, one to be launched shortly. You will be a project manager both for internal and external resources, and key in securing compliance with foremost European IVD regulations.
• Manage software development of new and existing products as Medical Device Software
• Establish and maintain software development environment compliant with regulatory standards and requirements
• Establish development processes and routines compliant with regulatory standards and requirements
• Responsible for software tool development, validation and maintenance
• Supervise and lead the development team in an agile and regulatory controlled environment
• Schedule and plan design reviews and software product release on designated deadlines
• Deliver product documentation compliant with European IVD regulations and FDA’s requirements regarding design control of IVD-products
• Regularly report project/development progress and deviations to Management
• Resource management for software development team
• Establish and maintain business relations with 3rd party software service suppliers
• Master of Science in Engineering, PhD or equivalent within relevant area
• At least 5 years relevant work experience according to below, or a PhD with minimum 2 years relevant work experience according to below
• Experience from product development and documentation in Medical Device Software
• Experience with a range of coding languages; familiarity with database architecture and structural query language (SQL) and Visual Basic language; knowing C programming language is a plus.
• Experience from developing software according to regulatory requirements in:
o ISO 13485 – Medical devices — Quality management systems
o IEC 62304 – Medical device software — Software life cycle processes
o ISO 14971 – Medical devices — Application of risk management to medical devices
o IEC 62366-1 – Medical devices — Application of usability engineering to medical devices
o US 21 CFR 820.30 – Design controls
• Knowledge about immunology, transplantation diagnostics and/or genetics is an advantage
• Strong leadership and communication skills
• Fluent in English and Swedish
If interested in the position, please e-mail your CV and cover letter to email@example.com as soon as possible.
Don’t hesitate to contact Daniel Kremer at mobile +46 (0)733 – 87 27 24 if you have any questions.