Purpose and Scope
As a key leadership role, the Software Development Director is accountable for managing and coordinating resources and processes to deliver software releases of Monteris products, while participating in defining the strategy for the product development team by driving initiatives that delivers the organization’s vision.
Primary Organization Responsibilities
• Produce plans for scope and timeline of software releases.
• Ensures adherence and compliance to the appropriate Quality Procedures and standards. Maintain Quality Procedures to the appropriate standards and industry best practices.
• Leads to the team for requirements, risk analysis, design, development, verification and validation, and releases software and firmware for Monteris products.
• Implements software launches and releases with full system validation and procedure support.
• Provides problem-diagnosis and solutions to clinical applications.
• Works together with the key stakeholders to plan and execute projects, ensure that teams have appropriate product and technical specifications, direction, and resources to deliver products effectively by establishing realistic estimates for timelines while ensuring that projects remain on target to meet deadlines.
• Works closely with the customers, field specialists and cross-functional teams to define the product requirements, including the Voice of the Customer and Voice of the Business.
• Provide software upgrades, enhancements, and fixes that are coordinated based on release schedules.
• Provides a software development plan that meets the future needs of Monteris clients and markets, based upon the state-of-the-art technologies.
• Evolves the existing software system applications and architecture in various areas as needed, including product cost reduction, international expansion, ease of use, and remote help support.
• Conducts daily brainstorming meetings as needed.
• Provides leadership and guidance to coach, motivate, and lead team members to their optimum performance levels and career development
• Support complaint investigation related to software.
• Defines resource needs for the team and closes on any gaps, including developers, tools and hardware.
Personal Qualifications and Experience
• Bachelor’s degree required in engineering, computer science, or other related field.
• Five to ten (5-10) years of software management experience.
• Knowledge of medical device software development preferred but not required.
• A strong technical background within Windows software development is required.
• Knowledge of development of embedded software preferred but not required.
• Experience with specific technologies including Microsoft Windows, COM/Automation, DHTML, Visual Studio, C++, Visual Basic, XML, etc. is an asset.
• FDA medical device software development experience; FDA and ISO quality system experience is strongly preferred.
• Possesses strong knowledge of all aspects of the software development process, product life cycles, and QA tools.
• Possesses strong communication, interpersonal, and organizational skills.
• Comfortable in a fast paced, evolving, and entrepreneurial organization.
• Sets a fast pace for the organization.
• Possesses the ability to be able to build product as required.
• Extremely comfortable with accountability and being challenged to improve both their organization and the company’s performance against quality goals.