Software Project Lead (Contract – 12 Months)

***C2C CONTRACTS WILL NOT BE CONSIDERED FORTHIS ROLE***

Location: Hybrid — onsite 3 days/week required
Work Authorization: Candidates must be authorized to work in the U.S. without visa sponsorship, now or in the future. Sponsorship is not available for this role.

About the Role
Our client, a global medical device manufacturer, is seeking a Software Project Lead for a 12-month contract to serve as the primary owner for software integration activities tied to recent acquisitions. This role is critical to aligning technical execution with business objectives, regulatory expectations, and product roadmaps — ensuring newly acquired software technologies are integrated responsibly into an established medical device portfolio while maintaining patient safety, regulatory compliance, and software quality.

Responsibilities

• Lead planning and execution of complex software development and integration initiatives
• Partner with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, and Operations to integrate software solutions into the medical device portfolio in 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 cross-functional teams
• Provide data-driven program status updates, risk assessments, and decision points to R&D leadership
• Drive alignment between legacy and acquired development processes, tools, architectures, and documentation
• Ensure development and integration activities comply with applicable industry standards
• Ensure proper integration of software lifecycle artifacts — 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 project progress and maintain transparent communication with cross-functional stakeholders, business sponsors, and senior management
• Conduct retrospectives and lessons-learned sessions, and implement process improvements

Key Competencies

• Ability to plan and execute software projects in the medical device industry; medical device software experience strongly preferred (new product development and sustaining software)
• Working knowledge of 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 WBS development, scheduling, and dependency tracking
• Working understanding of software-level challenges and system integration sufficient to support cross-functional execution
• Strong verbal and written communication skills, with the ability to collaborate across Software, Systems, Quality, and Regulatory teams to drive on-time delivery
• Strong organizational and problem-solving skills; ability to operate effectively within a regulated, quality-driven environment

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related technical discipline
• Minimum 5 years hands-on software development experience in C# and WPF
• 2+ years web technology experience 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 Qualifications

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