CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. The Software Development Manager is responsible for overseeing the development, implementation, and maintenance of software systems used in medical devices. This role involves managing a team of software engineers, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to deliver high-quality medical devices. Responsibilities: Lead a team of software engineers in designing, developing, and testing software for medical devices, ensuring compliance with industry standards and regulations. Assess and revise development process and procedures. Drive to a fuller implementation of the Agile methodology, improved productivity and higher quality Measure developer/team velocity per sprint, giving guidance as necessary Manage projects with the goal of delivering on-time, within scope and within budget Regulatory Compliance: Ensure that software development processes and documentation adhere to relevant regulatory requirements such as CE IVD regulations (e.g., 21 CFR Part 820), ISO 13485, and IEC 62304. Develop and maintain project plans, schedules, and budgets for software development projects, ensuring timely delivery of high-quality software products. Collaborate with cross-functional teams including hardware engineering, quality assurance, regulatory affairs, and clinical affairs to ensure alignment on project goals and timelines. Identify and mitigate risks associated with software development activities, including software defects, security vulnerabilities, and regulatory non-compliance. Drive continuous improvement initiatives to enhance software development processes, tools, and methodologies, ensuring efficiency and effectiveness in delivering software solutions for medical devices. Communicate regularly with internal stakeholders, including senior management, to provide updates on project status, issues, and risks. Managerial Qualifications: Bachelor’s Degree or equivalent experience 5+ years’ experience in management 5+ years’ experience in project management Understand Management is about Results, Retention, and Relationships Has experience building teams: Servant leadership, empowering team members, and supporting collaborative work practices Excellent time management and organizational skills Ability to establish relationships that facilitate successful outcomes Excellent problem-solving and strategic thinking skills Strong understanding of SDLCs including Waterfall and Agile/SCRUM Extensive knowledge of business applications, software design, production support and test methods Excellent verbal and written communication skills Experience with detailed cutover planning and execution Occasional travel may be required (10 – 15%) Technical Knowledge & Experience: Has managed teams developing in Java, C#, JavaScript/Typescript, React, Angular or other modern product development toolsets. Test Driven Development Delivering: CI/CD, Multiple Environments, Agile, Lean, or Kanban Familiarity with FDA regulations, ISO standards, and other regulatory requirements for medical device software. Web services and Microservices Cloud-Based Systems: Azure or Amazon Web Services Additional Details: Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients. Our competitive Total Rewards package includes: Competitive base salary and incentive compensation Health and welfare benefits including a gym reimbursement program 401(k) savings plan match Employee Stock Purchase Plan Pre-tax commuter benefits And more! In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow. With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together. CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us. #J-18808-Ljbffr
ISO standards Agile CI/CD Amazon Web Services (AWS) Azure JavaScript TypeScript Java React web-services Angular Kanban microservices C# Software Engineer