Manager – Software Development

Manager – Software Development

Requirements

• Bachelor’s degree (or an equivalent foreign degree) in Computer Science, Electrical or Electronics Engineering, Information Systems or a closely related field
• 7 years of experience as a Software Developer working with embedded software for medical devices
• 5 years of experience in embedded software design and development using C, C++, and object oriented design and Firmware development for microcontrollers including design and development of embedded software using Real Time Operating Systems (RTOS)
• Experience in Design and Implementation of Automated Testing Framework for Embedded Medical Devices using C#, Python and Windows PowerShell scripting
• Experience in Web design and database design including working with SQL server and Access
• Knowledge of Data security and cybersecurity of software systems
• Experience in Developing software in compliance with Medical Device Quality Systems and Regulatory Standards including ISO 13485, FDA Quality System Regulations (21 CFR 820), IEC 62304, ISO 14971 and 21 CFR Part 11
• Experience in Managing embedded software development projects for medical devices

Responsibilities

• Directing software systems development, software application development, and software quality assurance for software enhancements and new products
• Managing a team of software developers to design, code, test, and implement high quality software for dialysis and related products
• Planning, leading, assigning, supervising, and controlling activities related to software design and development
• Managing the tactical execution of short and long-term software development objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing
• Ensuring that the design and development of new software or modification to existing software meets the company’s business needs
• Managing and coordinating all phases of software development life cycle including the scheduling of resources, the development of design specifications from business requirements, cost estimation, standards, release management, software change management and process compliance
• Reviewing and evaluating quality of work performed by software engineers, prioritizing, assigning, and monitoring work progress relative to schedule plans
• Ensuring software development work satisfies business requirements, complies with approved department procedures and standards, and meets company software quality objectives
• Communicating project progress frequently and effectively to upper managers and team members
• Developing work estimates, work breakdown structures and the project work plan and preparing a consolidated work plan for initiatives that involve multiple related projects
• Providing technical contributions on key programs as required
• Contributing to the generation of ideas and potential inventions to be used in new products
• Maintaining current knowledge of state-of-the-art technologies to ensure the safety and quality of our products
• Serving as subject-matter expert on FDA Design Control procedures
• Providing leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce
• Participating and presenting at meetings with internal and external representatives, often leading a cooperative effort among members of a project team
• Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations

Preferred Qualifications

No preferred qualifications provided.