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Job Number : 2016
Job Title : Senior Director, Software Engineering / Product Development
Work Location : Portland, OR
 
Micro Systems Engineering, Inc (MSEI) is a pioneer in developing innovative technologies and medical devices that save and enhance the quality of life for millions of individuals living with cardiovascular disorders. The company is dedicated to the design and construction of implantable medical devices for cardiac rhythm management. With more than 30 years of experience, our growing success is based on our company’s core values – innovation, excellence and reliability, thus enabling us to inspire confidence and trust in doctors and patients all over the world. We are continually looking for talented engineers to share in our mission.



As a growing company, the Senior Director will develop and lead a world-class software organization that efficiently and effectively produces high quality medical devices. Provides a strong vision for the future of software engineering as it relates to the development of medical devices and defines a practical path to get there. The candidate will be responsible for the management of all phases of software design and development for medical device products from definition through release and maintenance. This requires significant breadth of knowledge and management of a broad range of disciplines beyond software including research, marketing, design, clinical, regulatory, manufacturing, quality, and testing. Success is measured by the on-time delivery of products that address key clinical and business needs of our customers and exceed industry standards for reliability and quality. The incumbent will lead either directly or through program leaders of multi-functional project teams.

Responsibilities

  • Form strategies with senior management on software technology direction and product solutions
  • Ensure software development plans are appropriately aligned, communicated and executed as they relate to corporate goals
  • Responsible for the software development of market-released medical products including the definition of requirements, allocation of resources, effective management of budgets, and on time execution of agreed plans and schedules
  • Definition of project scope and deliverables which includes support to other development teams and production and in particular support and definition to the product development organization for design and development of verification protocols and activities
  • Synchronization with cross-functional teams to support project planning and strategy implementation including timelines and resource allocations
  • Provide technical, clinical and regulatory support and initiative for activities focused on gaining market clearance in Europe, the US and other countries worldwide
  • Execute and support, through management and project teams, the completion of software projects and priorities
  • Enhance the software development lifecycle by applying industry best practices, processes and metrics
  • Ensure that all activities and work functions comply with company policies and procedures
  • Responsible for the employee career development, training, and motivation of the people in the department
  • Interface to senior management, finance, and regulatory agencies
  • Attract, develop, and retain technology talent that will achieve the product superiority objective
  • Partner with executive management to establish strategic plans and objectives for the function as well as organization
  • Drive the development of new software based technologies to bring novel products and applications to market
  • Consult with physicians on new and existing software based technologies, trends, and requirements for their uses


Qualifications

  • Advanced science degree in Electrical Engineering, Computer Science, Biomedical Engineering, or related field. Preferred: Master or PhD with MBA or advanced management training
  • 7-10 years of work experience in a medical device product development environment with 5-7 years managing software engineering or software centric product development projects
  • Preferred: Demonstrated experience in managing software design, implementation, debugging and verification in an embedded PC or deeply embedded environment including a deep knowledge of software architectures and technical trade-offs
  • Experience developing software for IEC62304 Class B or C medical devices
  • A passion for finding the right software technologies and software engineering methodologies to meet the challenges of medical device development
  • Demonstrated project management experience from project initiation to successful product introduction combined with an innovative working style with an emphasis on delegation and motivation of highly qualified software developers and management team
  • Ability to work synergistically with Marketing and R&D organizations to develop product specifications from demonstrated or perceived customer needs
  • Demonstrated high performance as indicated by successful product quality and project completion meeting both schedule and exceeding quality goals
  • Strong team player, self-motivated, self-directed, action oriented, able to learn quickly, mentor others, and influence all levels of management
  • Excellent written and verbal communication skills are required with experience in clear communication and interaction with senior management and regulatory agencies
  • Working knowledge of German a strong plus

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