IT-Software Development: Computer-Network Security, Database Development-Administration, Desktop Service and Support, Enterprise Software Implementation & Consulting, General-Other: IT-Software Development, IT Project Management, Network and Server Administration, Software-System Architecture
The Sustaining Software Manager’s primary responsibility is to lead a global team of engineers who develop, test and deploy software in the support of Medtronic’s commercialized Ventilation products. The Sustaining Software Manager works with ventilator products that are already in the marketplace.
The Software Engineering Manager will lead a team that is responsible for design history files, determining test requirements and coordinating and executing verification and validation testing. In addition to implementing design changes that either enhance performance or address quality issues, the team will support or lead complaint investigations, determines root cause failure modes and provide solutions for these issues.
Manage a team of technical personnel who provide support for the range of existing Ventilation products.
Identify and scope the required work. Organize and build detailed plans including schedules, resource budgets, quality and risk management plans, and verification and validation plans. Organize timely response to urgent situations.
Responsible for software configuration strategy, deployment and support. Establish operational objectives and provide technical direction and leadership.
Participate in system level design analyses, ensure consistency in design reviews, verification and validation efforts
Manage team and project communications, reporting and staffing. Ensure that the proper inputs are received and that the proper personnel/departments are involved in project decision making.
Coordinate with the global, cross functional business team at the design sites, manufacturing sites, service centers, etc. to prioritize and execute projects and resolve issues.
Manage the execution of the assigned projects. Prioritize and direct work. Work closely with project managers to ensure all project activities and deliverables are completed in a timely manner.
Provide technical leadership in solving engineering problems and fostering creativity and innovation in design and problem solutions.
Ensure design practices, test methodologies, and documentation meets the requirements of internal policies and external regulations. Adhere strictly to policies and procedures associated with an FDA controlled environment.
Be accountable for the technical completeness of the team’s output.
Be accountable for compliance with Design Control and Medical Device standards, such as FDA QSRs, ISO, IEC etc.
Actively assess each team member's and the team’s needs and gaps. Establish and execute plans for the development of each individual and the team as a whole.
Recruit, hire, evaluate, review, and retain high performing personnel.
Develop and lead process improvement efforts to allow for efficient work flows.
Minimum BS in Computer Science or Electrical Engineering with focus on Software.
10+ years in the design and development of software engineering solutions.
3+ years functional management experience, directly managing others.
2+ years of Medical device industry experience.
Competent in software development processes including design methodologies, source code management, build management, quality process, requirements-driven development, and the defect tracking and resolution process.
1+ years of experience managing software engineers and technical staff
1+ years of experience with internal and outsourced projects
Proven ability to partner cross functionally to successfully drive the business
Demonstrated relationship building skills and ability to influence without direct authority
Solid working knowledge of quality and regulatory requirements for medical devices, plus experience dealing with regulatory agencies or outside professional groups (e.g. FDA, ISO, ANSI, HIMA)
Strong communication skills, cross functionally, across all levels of the organization
Effective multi-tasker and problem solver with a high energy level and strong organizational abilities.
Attention to details, ability to think strategically and tactically.
Prioritization, Project Management and Team Building
San Jose, San Francisco CA
Phone: (866) 816-1615 x 823