Software Engineering Manager

Onsite in Dallas, TX

Direct Hire

We are seeking a Software Engineering Manager to lead software development for our drug delivery systems. This role will manage the software lifecycle, from development to maintenance, while ensuring compliance with medical device regulations. The manager will also oversee external electrical engineers involved in hardware development.

Key Responsibilities:

• Lead the development, testing, and deployment of software for drug delivery systems.
• Ensure compliance with SDLC best practices and regulatory requirements (IEC 62304, FDA, ISO 13485).
• Collaborate with hardware and regulatory teams to deliver integrated solutions.
• Oversee software maintenance, updates, and issue resolution.
• Manage software documentation and support regulatory submissions.

Qualifications:

• Bachelor's degree in Computer Science or related field (Master's preferred).
• 7-10 years of software development experience, including 3+ years in leadership.
• Experience with embedded software, real-time systems, and IoT technologies.
• Strong knowledge of FDA regulations and software standards (IEC 62304).