Pay Range: $60 to $69.04/Hour on W2
This role follows a hybrid work model, requiring employees to be in our local office at least three days per week.
About the role:
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.
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.
Key Competencies and Capabilities:
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.
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.
Working understanding of software day to day challenges and system level 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 and drive on time delivery.
Demonstrated organizational and problem solving skills, with the ability to manage assigned Product and operate effectively within a regulated, quality driven environment.
Required Qualifications:
Bachelor s degree in engineering, Computer Science, or related technical discipline.
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:
Experience developing Software for medical devices.
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.