The Program Manager directs the multi-phase product development process for medical devices and components from concept through market introduction and transfer to manufacturing. The role manages cross-functional projects that may include New Product Development, Manufacturing Transfer, Continuous Improvement Projects (CIPs) and semi-automation initiatives. The Program Manager is accountable for ensuring projects meet customer expectations across scope, schedule and budget, working closely with NPD, Business Development / Key Account Management, Quality, Manufacturing, Finance and other functions.

• Serve as the client's primary point of contact for all project-related matters.
• Drive on-time delivery performance and provide regular progress updates to relevant stakeholders.
• Write and review customer proposals and support business development and client relationship management activities.
• Prepare detailed project plans covering phases, tasks, interdependencies, durations, resource assignments and costs.
• Hold core teams accountable to agreed schedules, milestones and deliverables.
• Lead or participate in Phase Gate Reviews and ensure lessons learned and best practices are captured.
• Manage resource planning and staffing requirements for assigned projects.
• Maintain accurate project data, time tracking, reporting and status updates.
• Resolve project conflicts, establish appropriate escalation paths and facilitate issue resolution across project teams.
• Conduct project closeout meetings and post-completion reviews.
• Clearly communicate roles, expectations and accountabilities to project team members.
• Drive compliance with PMO processes, procedures and templates, and remove barriers to strategic objectives.
• Keep management informed of project risks, issues, status and mitigation actions.
• Work with functional managers to achieve project objectives, resolve resourcing issues and maintain on-time delivery.
• Set project budgets, track costs against budget and manage projects to financial targets, including invoice review and financial exposure.
• Direct day-to-day activity across multiple project teams through project planning, resource management, status reporting, risk management, issue resolution and accountability for deliverables.
• Manage multiple concurrent projects or programmes of varying size, scope and complexity for strategic customers.
• Support wider Project Management Office initiatives and coordinate with project managers responsible for sub-program deliverables.

• Bachelor's degree required; Master's degree preferred. A degree in Mechanical or Biomedical Engineering is desirable.
• Minimum 5 years of post-college experience in medical device product design and development or another regulated industry.
• Minimum 3 years of programme/project management experience, or relevant Project Management Professional (PMP®) certification.
• PMP® certification or equivalent project management training required.

• Knowledge of catheters, delivery systems, dilators or braided shafts is desirable.
• Proficient knowledge of FDA Quality System requirements and ISO 13485 medical device regulations.
• Strong written and verbal communication skills across both project and technical matters.
• Ability to interact professionally and with integrity with client companies and key stakeholders.
• Demonstrated problem-solving capability in situations of ambiguity and technical uncertainty.
• Strong negotiation, influencing and stakeholder-management skills.
• Ability to motivate and engage team members while demonstrating respect for people.
• Excellent time-management, organisation and prioritisation skills.
• Experience managing cross-functional teams in a matrix organisation with multiple stakeholders.
• Proficiency with Microsoft Project, online collaboration tools and databases.
• Flexibility, persistence, resourcefulness, customer focus and an entrepreneurial mindset.

The role involves regular computer-based work, meetings and interaction with cross-functional teams. The employee will regularly sit, stand, walk, communicate and review technical/project documentation. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Travel requirement: None to minimal.

The employer is committed to providing equal employment opportunities to all applicants and employees in accordance with applicable law.

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