Software Project Manager

REQ Solutions; Santa Clarita (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

REQ Solutions is seeking a Software Project Manager for a hybrid role focusing on medical device software development and integration. You will own software activities, coordinate cross-functional teams, and ensure alignment with regulatory requirements and product roadmaps.

The role requires extensive experience in regulated software lifecycles, strong leadership, and the ability to manage complex development programs across interfaces, data flows, and platform strategies.

Qualifications

• Bachelor’s degree in engineering or Computer Science or related technical discipline is required.
• 10-15 years of experience in software project management within software-driven medical devices or other regulated industries.
• Demonstrated experience leading cross-functional software development programs.
• Strong understanding of regulated software development lifecycles and quality systems.
• Proven ability to manage complex, ambiguous programs with multiple stakeholders.

Responsibilities

• Own software activities, aligning execution with business objectives, regulatory expectations, and roadmaps.
• Integrate acquired software technologies into the medical device portfolio to ensure safe products.
• Lead planning and execution of complex software development and integration efforts.
• Plan and execute software projects in the medical device industry, including new product development and sustaining software.
• Develop and maintain plans for software development, verification/validation, cybersecurity, and regulatory deliverables.
• Manage schedules, budgets, resources, risks, and interdependencies across cross-functional teams.
• Provide data-driven program status, risks, and decisions to R&D leadership.

Skills

Project management

Regulatory software development

Cross-functional leadership

SDLC in regulated environment

Data-driven status reporting

Education

Bachelor’s degree in engineering or Computer Science

10-15 years software project management in regulated industries

Master’s degree in Engineering or related field

Tools

MS Project

JIRA

Job description

Job Title: Software Project Manager (Medical Device)

Hybrid Role

Responsibilities:

• Serves as the primary owner for software activities, aligning technical execution with business objectives, regulatory expectations, and product roadmaps.
• Ensures that acquired software technologies are seamlessly and responsibly integrated into the medical device portfolio—turning strategic investments into safe, effective products for patients.
• Leading the planning and execution of complex software development and integration software.
• Ability to plan and execute software projects in the medical device industry, with preferred experience in medical device software, including new product development and sustaining software.
• Develop and maintain plans covering software development, verification/validation, cybersecurity, and regulatory deliverables.
• Manage program schedules, budgets, resources, risks, and interdependencies across multiple cross functional teams.
• Provide clear, data driven program status, risks, and decision points to R&D leadership.
• Drive alignment between legacy and acquired development processes, tools, architectures, and documentation.
• Work closely with software engineering teams to ensure development and integration activities comply with applicable standards.
• Ensure proper integration of software lifecycle artifacts, including requirements, architecture, risk management, verification, validation, and cybersecurity documentation.
• Support design reviews, phase gate reviews, and regulatory submissions related to integrated software products.
• Facilitate alignment on system architectures, interfaces, data flows, and platform strategies across organizations.
• Conduct retrospectives, and lessons learned, and implement process improvement initiatives to drive future success.
• Working knowledge of the software development lifecycle (SDLC) in a regulated environment, with exposure to agile or hybrid delivery models.
• Proficiency with project management and software delivery tools (e.g., MS Project, JIRA), including development of WBS, schedules, and dependency tracking.

Education/Experience:

• Bachelor’s degree in engineering, Computer Science, or related technical discipline.
• Software Development experience 5 years minimum C#, WPF Minimum 5 yrs.. hands on development experience
• Web technology Experience 2 yrs preferred
• 10-15 years of experience in software project management within software driven medical devices or other regulated industries.
• Demonstrated experience leading cross functional software development programs.
• Strong understanding of regulated software development lifecycles and quality systems.
• Proven ability to manage complex, ambiguous programs with multiple stakeholders.

Preferred:

• Familiarity with FDA, EU MDR, and global regulatory expectations for software enabled medical devices.
• Experience with cybersecurity, cloud-connected devices.
• PMP, PgMP, Agile, or SAFe certification.
• Master’s degree in Engineering, Management, or related field.