Zurich, Switzerland
Experienced leader within the medical device industry with proven track record in medical device development through all phases of product realization from idea screening to final transfer to production and product launch of internationally approved medical devices. Robust set of technical knowledge including vascular intervention and management skills formed through over 17-years working experience in research & development. Comprehensive knowledge regarding product development of vascular devices, processing of polymers, process development and filing (MDR/ FDA/ Japan) of medical devices. Familiar with the clinical environment, communication and interaction with international physicians (key-opinion leaders), experienced with peer-to-peer executive team members, management and development of employees. Distinctive analytical thinking and co-ordination skills. Proven ability to successfully go outside function, product, or country “silo” to understand how processes impact others and to implement best practices. Innovative mentality from hands-on to structured innovation management process.
- Execution of the strategies and plans developed by the board of directors. - Implementation of policies and procedures. - Management of day-to-day operations. - Contribution in tactical and strategy decisions of the company.
- Management of the research and development department. - Responsibility for planning, development and monitoring for plans and budgets for the department and project. - Implementation of a standardized budget and project planning tool. - Personal management of employees assigned to my department, ensuring the correct application of working tools, policies and required skills. - Identification, coaching and promotion of talents within the organization - Realization of vascular devices from idea to submission in alignment with MDR, FDA and PMDA. - Direct interaction and cooperation with international physicians. - Establishment and maintenance of the Design Control procedure according ISO 13485 and maintenance and update according to MDR requirements. - Driving innovation and creation of intellectual property. - R&D representative during internal and external audits. - Establishment of a regular reporting structure to executive management and management team.
- Team lead of remediation project in global cross functional activities in the US and Switzerland with up to 15 employees in orthopedics industry. - Sub-Project lead of device packaging within a cross-functional team in dental industry. - Remediation of design history file documentation in the orthopedics and dental industry. - Harmonization of global test standards and procedures. - Responsibility for creation and execution of statistically based testing strategies for design verification and design validation.