Job Title: Director of Software Development
Job Number: 25010
The Director of Software Development is a hands-on leader of Software Engineering and Verification and Validation (“V&V”) teams. The software development team delivers embedded and application product 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 will develop a software development roadmap and software architecture for the product platform, develop tools and processes for development and testing and develop 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.
- Hire, develop and lead personnel to build a best-in-class Software Development team.
- Custom Software / Firmware development, verification, and validation in support of 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.
- Recommend software development roadmap for 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 / or 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
- 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 Programming
- 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