Software Project Lead

Canon Recruiting Group•Valencia, CA

4d•Hybrid

About The Position

This role serves as the primary owner for software activities, aligning technical execution with business objectives, regulatory expectations, and product roadmaps. As a key member of the Software group and is critical to accelerating innovation through acquisition while maintaining patient safety, regulatory compliance, and software quality. The Software Project Lead ensures that acquired software technologies are seamlessly and responsibly integrated into the medical device portfolio—turning strategic investments into safe, effective products for patients.

Requirements

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
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.

Nice To Haves

Web technology Experience 2 yrs prefered
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.

Responsibilities

Leading the planning and execution of complex software development and integration software.
Partnering closely with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, Operations and other cross-functional teams to develop software solution into the company’s medical device portfolio while ensuring compliance with global regulatory standards and internal quality systems.
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.
Drive issue resolution and decision making across organizational boundaries.
Track software project progress and provide transparent communication and interfaces with all areas affected by the project including cross-functional stakeholders, business sponsors, and senior management.
Conduct retrospectives, and lessons learned, and implement process improvement initiatives to drive future success.
Additional duties, as assigned.