STEM Recruitment Partners are representing a leading medical device R&D company based in Dublin, Ireland. We are seeking a highly experienced Software Project Manager for a 12-month contract, offering a lucrative hourly rate.

JOB REQUIREMENTS

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.
• Minimum 8 years’ experience in medical device R&D, with at least 5 years managing software development projects in a regulated environment.
• Proven track record delivering complex software projects for medical devices, preferably Class II/III.
• In-depth understanding of medical device software development lifecycle, including design controls, verification/validation, and risk management.
• Hands-on experience with IEC 62304, coding standards (MISRA-C/C++), and regulatory submissions (FDA 510(k), EU MDR).
• Proficiency with project management and ALM tools (JIRA, Jama, SysML, Enterprise Architect).
• Strong technical background in embedded systems, firmware, or software engineering (assembler, C/C++, Java, .NET).
• Familiarity with real-time operating systems (QNX, SafeRTOS, Linux) and microcontroller platforms (iMX6, iMX8, NXP, PIC).
• Experience with agile methodologies (Scrum, Kanban) and test-driven development.
• Outstanding communication, leadership, and stakeholder management skills.

DESIRABLE QUALIFICATIONS

• PMP, PRINCE2, or equivalent certification.
• Experience with safety-critical systems and cybersecurity in medical device software.
• Exposure to advanced connectivity (WiFi/BLE/Cellular) and automated testing tools (VectorCast, TeamCity).

ABOUT THE ROLE

As the Software Project Manager, you will lead the delivery of complex software projects for critical care medical devices. This role requires extensive project management experience in the medical device R&D sector, deep technical expertise, and a proven ability to drive cross-functional teams in a regulated environment.

JOB RESPONSIBILITIES

• Lead the planning, execution, and delivery of software projects for new and existing medical devices, ensuring compliance with regulatory and quality standards.
• Define project scope, goals, deliverables, and success criteria in collaboration with engineering, quality, and regulatory teams.
• Develop and manage detailed project plans, schedules, resource allocation, and budgets.
• Oversee requirements gathering, risk management, and change control processes using tools such as JIRA, Jama, and SysML.
• Ensure all software development activities comply with IEC 62304, FDA, ISO 13485, and other relevant standards.
• Facilitate cross-disciplinary collaboration among software, hardware, mechanical, and quality teams.
• Monitor project progress, manage stakeholder communication, and report status to senior leadership.
• Lead technical problem-solving, provide guidance, and resolve project roadblocks.
• Mentor and coach team members, fostering a culture of continuous improvement and regulatory excellence.
• Prepare and review regulatory submission documentation (e.g., FDA 510(k)), ensuring audit readiness.