Project Specialist II

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.