Senior Project Manager – Medical Device Development

• Lead medical device programs through discovery, feasibility, requirements, design development, prototyping, verification, validation, design transfer and production readiness
• Create and maintain integrated project plans covering scope, deliverables, work breakdown, schedule, budget, resourcing, dependencies, stage gates, quality activities and decision criteria
• Act as the primary client interface for delivery, provide clear reporting, facilitate decisions and align technical work with contractual, commercial, regulatory and business objectives
• Lead multidisciplinary teams, define accountabilities, coordinate internal and external contributors, remove delivery constraints and maintain effective operating rhythms
• Apply applicable QMS and project governance frameworks, including design and development planning, requirements and traceability, risk management, reviews, verification and validation, change control, configuration and record control
• Plan and facilitate project kick-offs, technical reviews, design reviews, end-of-phase reviews and governance forums; record decisions, actions, approvals and objective evidence
• Own project risk, issue, assumption and dependency management, including escalation, mitigation planning and closure tracking
• Manage project finances, estimates, forecasts, purchasing inputs, supplier commitments, variations and scope changes; protect delivery margin while maintaining quality and client outcomes
• Coordinate prototype and pilot builds, supplier engagement, test readiness, verification and validation execution, nonconformity resolution and design transfer activities
• Ensure project documentation and the Design History File are structured, controlled, current and auditable, with clear links between user needs, requirements, risks, outputs and verification evidence
• Guide teams in balancing safety, usability, technical performance, manufacturability, serviceability, regulatory needs, cost and schedule
• Support proposals, project scoping, delivery estimates and client workshops, and contribute to continuous improvement of project and medical device development practices
• Work with multidisciplinary teams and senior client stakeholders on regulated medical device programs from early concept through design transfer

• Substantial experience leading end-to-end medical device or similarly regulated product development programs in a consultancy, manufacturer or technology business
• Demonstrated delivery of complex electromechanical products involving multiple engineering disciplines, suppliers and manufacturing partners
• Working knowledge of ISO 13485 design controls and ISO 14971 risk management
• Practical experience with requirements, traceability, design reviews, verification, validation and design transfer
• Strong project controls capability across planning, scheduling, resource management, budget control, forecasting, risk, change and executive reporting
• Ability to translate ambiguous commercial, user, technical and regulatory inputs into an executable development plan and clear team priorities
• Credible client leadership, negotiation and facilitation skills
• Experience communicating with executives, technical specialists, quality and regulatory stakeholders
• Experience managing controlled documentation, review and approval workflows, action registers, decision logs and development records within a QMS
• Practical understanding of product development, prototyping, test planning, supplier engagement, manufacturing processes and production transfer
• Tertiary qualification in engineering, science, industrial design, project management or a related discipline, or equivalent relevant experience
• Project or program management certification such as PMP or PRINCE2 is highly regarded
• Experience with active, software-enabled, connected, diagnostic, therapeutic, laboratory or clinical-use devices is highly regarded
• Familiarity with IEC 62304, IEC 60601, IEC 62366-1, FDA, TGA or EU MDR expectations is highly regarded
• Experience preparing or supporting regulatory submissions, technical documentation, clinical or usability activities, supplier qualification, CAPA or audits is highly regarded
• Consultancy experience across parallel client engagements, proposals, commercial variations and fixed-price or milestone-based delivery is highly regarded
• Experience mentoring project managers and improving delivery systems, templates and governance practices is highly regarded

• Flexible work arrangements, including remote work and flexible work hours
• Career growth programs
• Access to certifications in technologies such as AWS and Microsoft Azure
• Opportunities across diverse professions
• Healthy work-life balance support