Med Device Software Project Lead (PMO)

TALENT Software Services; Santa Clarita (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

TALENT Software Services is seeking an Associate Project Manager to join its PMO for software product development in the medical device space. You will align technical execution with business objectives, regulatory expectations, and roadmaps, working across R&D, Quality, Regulatory and IT teams to ensure compliant delivery.

You will drive planning, lifecycle artifact integration, and regulatory submissions while supporting risk management and continuous process improvements.

Qualifications

• 2–4 years of PM experience in software-driven medical devices or regulated industries.
• Software engineering or related field with med device experience is needed.
• Familiarity with IEC 62304, ISO 14971, ISO 13485 is a plus.

Responsibilities

• Lead planning and execution of software systems development projects and workstreams.
• Develop and maintain project plans covering software development, verification/validation, cybersecurity, and regulatory deliverables.
• Collaborate with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, Operations and other cross-functional teams to ensure compliance with standards (IEC 62304, ISO 14971, ISO 13485).
• Ensure integration of software lifecycle artifacts (requirements, architecture, risk management, verification, validation, cybersecurity).
• Track progress, manage budgets, and communicate status to stakeholders.
• Support design reviews, phase gate reviews, and regulatory submissions for integrated software products.
• Provide data-driven program status, risks, and decisions to stakeholders.
• Drive issue resolution and decision making within projects.
• Conduct retrospectives and implement process improvements.
• Additional duties as assigned.

Skills

Project management

Regulatory compliance

Cross-functional collaboration

Risk management

Education

Bachelor's degree in Engineering, Computer Science, or related technical discipline

Job description

TALENT Software Services is seeking an Associate Project Manager to join its PMO for software product development in the medical device space. You will align technical execution with business objectives, regulatory expectations, and roadmaps, working across R&D, Quality, Regulatory and IT teams to ensure compliant delivery.

You will drive planning, lifecycle artifact integration, and regulatory submissions while supporting risk management and continuous process improvements.