Director, Software Development

Description

The Director of Software Development is a hands-on leader of Vero’s Software Engineering and Verification and Validation (V&V) teams. The Vero software development team delivers embedded, application, and cloud services platform software in support of product development for a portfolio of critical care and home use medical and drug delivery products and systems. The team also owns sustaining engineering of software on existing products, software V&V and software system development and validation for manufacturing systems. In addition, the Software Development team creates software development roadmaps and software architecture for core product platforms, tools and processes for development and testing and best-practice processes for tracking software changes and bugs as well as conducting design and code reviews. Responsibilities for this role will also include hiring and developing personnel, leading a team/managing cross-functional projects, ensuring compliance with governing Quality Management System requirements and overall Regulatory compliance. Experience developing mission critical, highly reliable, complex software for medical, aerospace, automotive and/or military applications following design control procedures is required. Experience developing applications for mobile and cloud-based environments is a plus.

• Lead and develop a best-in-class Software Development team.
• Custom Software / Firmware & Cloud Services Platform development, verification, and validation in support of Vero Biotech’s combination medical products.
• Lead design reviews, code reviews, and software architecture reviews
• Serve as the technical expert in software development and provide guidance and mentoring to others.
• Champion best practices and implement and manage software development tools and procedures to support these practices.
• Create software development roadmaps for Vero Biotech product development efforts.
• Evaluation, Application, Customization, System Integration of new technologies
• Drive necessary changes to existing software / hardware / firmware to correct software anomalies, allow the software to adapt to new hardware, and to improve performance.
• Direct code development, software testing, and documentation in accordance with current procedures, international standards, and FDA regulations
• Analyze user needs and software requirements to determine feasibility of design within time and cost constraints
• Confer with engineers, programmers and others to define the architecture, design the system and to obtain information on project limitations and capabilities, performance requirements and interfaces
• Define test strategy, develop protocols and oversee software verification and validation efforts
• Manage multiple projects to deliver results within design specifications and budget restrictions
• Investigate and thoroughly understand on-going developments and advancements in the field of software engineering and governing standards
  
  

Qualifications

• Bachelor’s degree (B.S.) in Computer Science, Computer Engineering or Electrical Engineering; Master’s degree preferred.
• 15+ years experience in software development and testing
• 5+ years related experience or equivalent in medical device software development and testing
• 5+ years experience leading and managing teams of 6 to 10 individuals
• Experience developing mission critical device control applications for stand-alone systems with a graphical user interface and customized, application-specific hardware systems.
• Experience in defining and developing custom algorithms and feedback controls for electromechanical systems.
• Experience with human factors and user centered design a plus
• Experience with Windows based embedded and/or Windows IoT development using C# preferred
• Experience with microcontroller development in C and C++ preferred
• Experience with embedded Linux development preferred
• Experience managing and/or directing software development projects
• Experience with software development tools and procedures
• Experience in all aspects of the product development lifecycle
• Knowledgeable of IEC 62304 and development under FDA compliant procedures
• Knowledgeable of risk management techniques and procedures defined by ISO 14971, FDA guidance, and other international standards
• Proficient in Software Engineering, Data Structures, and Object-Oriented Programing
• Experience working within product development quality system
• Commitment to excellence and high standards
• Excellent written and oral communication skills
• Strong leadership, management, organizational, problem-solving, and analytical skills
• Ability to manage personnel, projects, priorities and workflow in a fast-paced environment.
• Demonstrated ability to plan and organize projects