Program Manager – Medical Devices

Program Manager: An innovative medical device company in Dublin is seeking a Program Manager to drive the success of strategic projects and initiatives. In this role, you will lead cross-functional teams, ensuring alignment with business objectives and the successful delivery of innovative medical devices that improve patient care.

This position requires a blend of technical expertise and a deep understanding of quality and regulatory standards within the medical device industry, ensuring compliance while driving innovation and efficiency.

REQUIREMENTS: 

• Degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a similar related field.
• 5+ years of experience in program management, specifically within the medical device industry or a closely related field (e.g., healthcare, biomedical engineering).
• PMP (Project Management Professional), PgMP (Program Management Professional), or similar certifications.
• Strong leadership abilities and experience managing cross-functional teams.
• Deep understanding of medical device development processes, including design control, validation and regulatory compliance.
• Ability to communicate effectively with diverse stakeholders, from technical teams to senior executives.
• Expertise in program management tools (e.g., Microsoft Project, JIRA, or similar).
• Strong problem-solving, critical thinking, and decision-making skills.
• Experience with medical device product lifecycle management and quality management systems.
• Detail-oriented, proactive, adaptable, with a focus on continuous improvement and patient outcomes.
• Willingness to travel internationally.

RESPONSIBILITIES: 

• Lead and manage multiple programs that span the lifecycle of medical device development, from ideation through design, development, and regulatory approval, ensuring alignment with the company’s strategic goals.
• Cross-functional Collaboration: Work closely with product development, engineering, quality assurance, regulatory affairs, and commercial teams to ensure successful program execution.
• Stakeholder Communication: Regularly communicate program progress, risks, and milestones to senior management and key stakeholders. Ensure that expectations are properly set and managed across all involved parties.
• Regulatory Compliance: Ensure that all programs comply with relevant regulatory requirements (e.g., FDA, CE, ISO), managing documentation, testing, and approvals needed for device market entry.
• Quality Control: Oversee the quality assurance processes, ensuring the product meets the highest industry standards, regulatory requirements, and customer expectations.
• Resource Allocation: Manage resources effectively across multiple projects, ensuring teams are properly staffed and projects are completed on time and within budget.
• Process Improvement: Continuously assess and enhance internal processes and methodologies to improve the efficiency, quality, and speed of program delivery.
• Budget and Schedule Management: Monitor and control program budgets, providing financial oversight and making sure timelines are adhered to.
• Team Leadership: Lead and mentor cross-functional teams, promoting collaboration, accountability, and a high-performance culture.