Senior Project Manager – Medical Device Development

This is a fully remote position, open to applicants in Australia.

📋 Description

• Oversee medical device initiatives from discovery and feasibility through to requirements gathering, design development, prototyping, verification, validation, design transfer, and readiness for production.

• Develop and manage comprehensive project plans that encompass scope, deliverables, work breakdown structure, scheduling, budgeting, resource allocation, dependencies, stage gates, quality activities, and decision criteria.

• Serve as the main client liaison for project delivery, ensuring transparent reporting, facilitating decision-making, and aligning technical efforts with contractual, commercial, regulatory, and business goals.

• Lead cross-functional teams, clarify responsibilities, coordinate contributions from internal and external parties, eliminate delivery obstacles, and uphold effective operational rhythms.

• Implement relevant Quality Management Systems (QMS) and project governance frameworks, including planning for design and development, requirements traceability, risk management, reviews, verification and validation, change control, and configuration management.

• Organize and lead project kick-off meetings, technical reviews, design assessments, end-of-phase evaluations, and governance forums; document decisions, actions, approvals, and objective evidence.

• Manage project risks, issues, assumptions, and dependencies, including escalation processes, mitigation strategies, and tracking of resolutions.

• Oversee project financials, including estimates, forecasts, procurement inputs, supplier commitments, variations, and scope adjustments; safeguard delivery margins while ensuring quality and client satisfaction.

• Coordinate prototype and pilot production, supplier interactions, test readiness, execution of verification and validation, resolution of nonconformities, and design transfer processes.

• Ensure that project documentation and the Design History File are well-organized, controlled, up-to-date, and auditable, with clear connections between user needs, requirements, risks, outputs, and verification evidence.

• Assist teams in balancing factors such as safety, usability, technical performance, manufacturability, serviceability, regulatory requirements, cost, and timelines.

• Support proposal development, project scoping, delivery estimates, client workshops, and contribute to the ongoing enhancement of project and medical device development practices.

• Collaborate with cross-functional teams and senior client stakeholders on regulated medical device programs from initial concept through to design transfer.

⛳️ Requirements

• Extensive experience in leading comprehensive medical device or similarly regulated product development programs within a consultancy, manufacturing, or technology setting.

• Proven track record of delivering complex electromechanical products that involve multiple engineering disciplines, suppliers, and manufacturing partners.

• Familiarity with ISO 13485 design controls and ISO 14971 risk management principles.

• Hands-on experience with requirements management, traceability, design reviews, verification, validation, and design transfer processes.

• Strong capability in project control, including planning, scheduling, resource management, budget oversight, forecasting, risk management, change management, and executive reporting.

• Ability to convert vague commercial, user, technical, and regulatory inputs into a feasible development plan with well-defined team priorities.

• Demonstrable client leadership, negotiation, and facilitation skills.

• Experience in communicating effectively with executives, technical experts, quality and regulatory stakeholders.

• Background in managing controlled documentation, review and approval workflows, action logs, decision registers, and development records within a QMS framework.

• Practical knowledge of product development, prototyping, test planning, supplier engagement, manufacturing processes, and production transfer.

• Bachelor's degree in engineering, science, industrial design, project management, or a related field, or equivalent relevant experience.

• Project or program management certification such as PMP or PRINCE2 is highly valued.

• Experience with active, software-enabled, connected, diagnostic, therapeutic, laboratory, or clinical-use devices is highly preferred.

• Familiarity with IEC 62304, IEC 60601, IEC 62366-1, FDA, TGA, or EU MDR standards is advantageous.

• Experience in preparing or assisting with regulatory submissions, technical documents, clinical or usability activities, supplier qualifications, CAPA, or audits is a plus.

• Consultancy experience across multiple client engagements, proposals, commercial variations, and fixed-price or milestone-based projects is highly regarded.

• Proven experience mentoring project managers and enhancing delivery systems, templates, and governance practices is a plus.

🏝️ Benefits

• Flexible work arrangements, including options for remote work and adaptable hours.

• Opportunities for career advancement through dedicated growth programs.

• Access to certification programs in technologies such as AWS and Microsoft Azure.

• Diverse opportunities across various professions.

• Support for maintaining a healthy work-life balance.