Software Engineering Manager

Nihon Kohden Orange Med - Santa Ana, CA

Full-time - Manager

Santa Ana, CA

About the position

The Software Engineering Manager will play a crucial role in the engineering management team, responsible for leading and developing the software engineering team. This position involves overseeing software development for new product designs and maintaining existing software designs, ensuring that projects are completed on time and adhere to industry standards.

Responsibilities

• Lead a team of software engineers in the design, development, and maintenance of software products.
• Promote best practices for software development lifecycles in accordance with FDA guidelines and ISO 62304.
• Assist in product and project management for software development activities, ensuring proper allocation of resources, tasks, workflows, and timelines.
• Collaborate with Regulatory Affairs (RA) and Quality (QA) teams for software-related activities for product registration.
• Mentor and train team members to enhance their technical skills and promote career growth.
• Adhere to all company policies, procedures, and business ethics codes.

Requirements

• Bachelor's degree in computer science, engineering, or a related field.
• Master's degree preferred.
• Minimum of 10 years of experience in software development.
• Minimum of 10 years of direct experience with real-time embedded software development for high reliability critical care medical devices.
• Strong proficiency in C/C++ and multi-threaded software development.
• Experience with object-oriented architecture and design.
• Experience with unit level testing and code review for high reliability software verification testing.
• Strong knowledge of FDA software documentation and test requirements for 510K submissions.
• Excellent leadership and communication skills.

Nice-to-haves

• Experience in critical care medical devices.
• Experience with training and mentoring team members.

Benefits

• Full-time position with standard work hours.
• Occasional travel may be required.