Company description:

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D; and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same

Job description:

Your role

In this role, you will lead high-impact medical device programs where engineering rigour, commercial delivery and patient-centered outcomes intersect. You will work with experienced multidisciplinary teams, engage directly with senior client stakeholders and help shape regulated products from early concept through to design transfer.

We are seeking a senior project leader to direct technically complex, regulated medical device development programs for clients ranging from emerging ventures to established global organizations. You will combine disciplined program delivery, practical knowledge of medical device design controls, commercial judgement and confident client leadership to turn ambiguous product and regulatory challenges into well-controlled development programs.

Working across industrial design, systems, mechanical, electronics, firmware, software, UX/UI, quality, regulatory, suppliers and manufacturing partners, you will establish the delivery strategy, maintain control of scope, cost, schedule, resources and risk, and ensure development evidence is complete, coherent and ready for regulatory submission.

You will play a key role in:

- 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, providing clear reporting, facilitating decisions and aligning 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 the applicable QMS and project governance framework, 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.

Profile description:

- 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,



with practical experience of 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, including the ability to communicate 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.

Highly regarded

- Project or program management certification such as PMP, PRINCE2 or equivalent demonstrated practice.

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

- Familiarity with IEC 62304, IEC 60601, IEC 62366-1, FDA, TGA or EU MDR expectations relevant to the programs led.

- Experience preparing or supporting regulatory submissions, technical documentation, clinical or usability activities, supplier qualification, CAPA or audits.

- Consultancy experience across parallel client engagements, proposals, commercial variations and fixed-price or milestone-based delivery.

- Experience mentoring project managers and improving delivery systems, templates and governance practices

We offer:

- We recognise the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
- At the heart of our mission is your growth opportunities. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- Equip yourself with valuable certifications in the latest technologies such as AWS and Microsoft Azure

📌 Senior Project Manager -Medical Device Development (Sydney)
🏢 Capgemini Australia
📍 Sydney