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About the Role

Lead high-impact medical device programs where engineering rigour, commercial delivery and patient-centered outcomes intersect. Work with experienced multidisciplinary teams, engage directly with senior client stakeholders and help shape regulated products from early concept through to design transfer.

Responsibilities

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.

Requirements

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.

Skills

Project management
Program management
ISO 13485
ISO 14971
Design controls
Risk management
Requirements traceability
Design reviews
Verification
Validation
Design transfer
Planning
Scheduling
Resource management
Budget control
Forecasting
Risk management
Change management
Executive reporting
Client leadership
Negotiation
Facilitation
QMS
Documentation management
Product development
Prototyping
Test planning
Supplier engagement
Manufacturing processes
Production transfer
PMP
PRINCE2
Active devices
Software-enabled devices
Connected devices
Diagnostic devices
Therapeutic devices
Laboratory devices
Clinical-use devices
IEC 62304
IEC 60601
IEC 62366-1
FDA
TGA
EU MDR
Regulatory submissions
Technical documentation
Clinical activities
Usability activities
Supplier qualification
CAPA
Audits
Consultancy
Mentoring

Experience Level

Senior

Education Level

Tertiary qualification in engineering, science, industrial design, project management or a related discipline, or equivalent relevant experience.

Benefits

Flexible work arrangements
Remote work options
Flexible work hours
Career growth programs
Support for certifications in AWS and Microsoft Azure

About the Company

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.
Capgemini is the business transformation partner for enterprises in the age of AI. We help organizations imagine and build an intelligent, sustainable future, combining AI, technology and human ingenuity to transform how they operate, innovate and grow.
With unique end-to-end capabilities spanning strategy, technology, engineering and intelligent operations, we bring together deep industry expertise and market-leading capabilities in AI, cloud and data to turn ambition into measurable business outcomes at scale.
Supported by a robust ecosystem of partners and nearly 60 years of expertise, Capgemini is a responsible and diverse global organization of over 410,000 team members in more than 50 countries.