Project Leader

Job Purpose:

• The executive would be responsible for development projects in the field of medical technology to ensure compliance with cost, time and quality specifications.
• Coordination of tasks for the development of medical products and processes while implementing and complying with the normative regulations for the development process (e.g. ISO13485, ISO 62304, ISO 14971).
• Leadership of interdisciplinary project teams. Close collaboration with project staff from development, product management, production, regulatory affairs, and other disciplines. Collaboration with external partners.
• Responsibility for active regular communication with all project participants and stakeholders. Primary interface for efficient communication between the Indian development center and the global management teams in Europe and the USA.

Team:

• Would have functional and disciplinary responsibility of the subordinate employees.
• Work with Software Engineers, Mechanical Engineers, System Engineers, Product Managers, 3rd Party Vendors, Service and Production Personnel with low level of supervision. The leader will be required to work closely with both internal and external customers.

Responsibilities:

• Technical and disciplinary leadership of a development team in India consisting of hardware and software engineers, architects and Quality Assurance.
• Work as a member of interdisciplinary development teams to develop medical imaging devices
• Leading project teams and coordinating with the various disciplines from all departments
• Determine project feasibility & timeframe
• Overall responsibility from project start until launch and making sure to launch the product on schedule underlined by high quality thinking
• Ensure compliance to regulatory requirements for medical devices
• Ensure complete project and product documentation (technical file) until launch
• Direct interface with Product Management
• Forges strong relationships across departments and to other companies
• Organization of project and review meetings on a regular basis and reporting to the corresponding decision-making body along the defined governance structure
• Collaboration with suppliers
• Ensuring the efficient introduction of products in production and their technical support
• Coordination of product change requests during the product life cycle
• Ensuring team motivation and integration of the corporate culture

Key Skills:

• Proven track record of successfully implementing several end-to-end medical device developments in an international environment in a leading role
• Leadership qualities in an interdisciplinary environment
• Excellent project planning and estimating skills; drives projects and keeps them moving through daily obstacles; asks for additional assistance when appropriate.
• Knowledge of agile project methodology is a plus
• Excellent communication skills. Has forged relationships with development personnel throughout the company.
• Self-motivated; works with minimal supervision.
• Confident in an international environment and understanding of western culture (EU, USA)
• Enthusiastic about the company and about developing its high-quality medical products.
• Recognizes problems and offers solutions. Helps the group adapt to changing conditions.
• Knowledge of medical device quality system regulations and standards (e.g., U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) is a plus
• Able to motivate a development team and communicate the product vision and corporate culture
• Excellent verbal and written skills (also in business English)

Qualification & Experience

• Master of Science or related field, minimum 18 years of experience in the development of medical devices
• At least 6 years in the management of medical product development in an international, interdisciplinary environment
• At least 2 end-to-end medical device developments in a project management role
• Comprehensive experience with western culture.
• Must have good organizational skills and time management skills.
• Must be willing to work together with remote teams in Europe and US.
• Must be flexible in terms of working hours to be able to react to time zone differences of the distributed development teams.
• Should be willing to potentially move workplace nationally / locally.
• Knowledge of MS Office.
• Project Management Certification is a plus.