Project Specialist II

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

Description:

Job Purpose

This role serves as a project manager within the R&D organization to support software product development activities, including aligning technical execution with business objectives, regulatory expectations, and product roadmaps.

As a member of the PMO group, this role will help accelerate innovation while maintaining patient safety, regulatory compliance, and product quality. The Associate Project Manager will support efforts related to acquired software technologies to ensure they are seamlessly and responsibly integrated into the medical device portfolio.

Key Responsibilities

• Leading the planning and execution of projects and workstreams within complex software systems development programs.
• Develop and maintain project and workstream plans covering software development, verification/validation, cybersecurity, and regulatory deliverables.
• Partner with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, Operations and other cross-functional teams to ensure development activities comply with applicable standards (e.g., IEC 62304, ISO 14971, ISO 13485).
• Ensure proper integration of software lifecycle artifacts, including requirements, architecture, risk management, verification, validation, and cybersecurity documentation.
• Track project progress, manage budgets, and provide transparent communication and interfaces with all areas affected by the program/project, including cross-functional stakeholders, business sponsors, and senior management.
• Support design reviews, phase gate reviews, and regulatory submissions related to integrated software products.
• Provide clear, data-driven program status, risks, and decision points to stakeholders.
• Drive issue resolution and decision making within the project or workstream.
• Conduct retrospectives and lessons learned, and implement process improvement initiatives to drive future success.
• Additional duties, as assigned.

Quality Systems Duties and Responsibilities

Build Quality into all aspects of their work by maintaining compliance with all quality requirements.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or related technical discipline.
• 2-4 years of experience in program or project management within software-driven medical devices or other regulated industries.
• Software engineering or related field with med device experience is needed.

Preferred Qualifications

• Familiarity with FDA, EU MDR, and global regulatory expectations for software-enabled medical devices.
• Experience with cybersecurity, cloud-connected devices, or mobile health platforms.
• PMP, PgMP, Agile, or SAFe certification.