Manager, Software Development

Manager, Software Development, Fresenius USA , Inc., a Fresenius Medical Care N.A. company, Martinez, California (Hybrid) Responsible for directing software systems development, software application development, and software quality assurance for software enhancements and new products including cloud-based and/or internet-related tools. Will manage a team of software developers to design, code, test, and implement high quality software for dialysis and related products. Will also be responsible for planning, leading, assign, supervising, and controlling activities related to software design and development.

Specific duties include:

• Manages 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.
• Ensures that the design and development of new software or modification to existing software meets the company's business needs.
• Manages and coordinates 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.
• Reviews and evaluates quality of work performed by software engineers, prioritizing, assigning, and monitoring work progress relative to schedule plans, in addition to adjusting levels of work effort and/or schedule exceptions to ensure the integrity of the software development plan.
• Ensures software development work satisfies business requirements, complies with approved department procedures and standards, and meets company software quality objectives.
• Communicates project progress frequently and effectively to upper managers and team members, working effectively within the organization to evaluate project results.
• Develops work estimates, work breakdown structures and the project work plan and prepares a consolidated work plan for initiatives that involve multiple related projects.
• Provides technical contributions on key programs as required.
• Contributes to the generation of ideas and potential inventions to be used in new products.
• Maintains current knowledge of state-of-the-art technologies to ensure the safety and quality of our products.
• Serves as subject-matter expert on FDA Design Control procedures.
• Provides leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce.
• Participates and presents 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.

Requirements:

Position requires a Bachelor's degree (or an equivalent foreign degree) in Computer Science, Electrical or Electronics Engineering, Information Systems or a closely related field and 7 years of experience as a Software Developer working with embedded software for medical devices. Must also have 5 years of experience (which can have been gained concurrently with the primary experience requirement above), working with the following:

• 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 );
• Design and Implementation of Automated Testing Framework for Embedded Medical Devices using C#, Python and Windows PowerShell scripting;
• Web design and database design including working with SQL server and Access;
• Data security and cybersecurity of software systems;
• 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;

• Managing embedded software development projects for medical devices. This is a hybrid position working 2 days/week at the company's office in Martinez, CA and 3 days/week working from home. Salary is $274,456
• 301,682 per year for a 40-hour work week.

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