Remote Senior Medical Device Program Leader

Capgemini; Sydney; Presencial; AUD 180 000 - 260 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible work arrangements

Career development programs

Certification opportunities (AWS/Azure

Resumo da oferta

Capgemini Engineering in Australia seeks a Senior Project Manager to lead technically complex, regulated medical device development programs. You will direct multidisciplinary teams and engage directly with senior client stakeholders to shape products from concept through design transfer.

You will apply QMS and project governance, manage scope, cost and risk, and ensure development evidence is complete for regulatory submission, while mentoring peers and contributing to continuous improvement.

Qualificações

• Substantial experience leading end-to-end medical device programs.
• Experience with ISO 13485 and ISO 14971 is preferred.
• Experience in consultancy, manufacturing or technology businesses.

Responsabilidades

• Lead medical device programs from discovery to production readiness.
• Direct multidisciplinary teams and manage scope, cost and schedule.
• Serve as primary client interface with clear reporting and decisions.
• Apply QMS and governance covering design reviews, V&V and risk management.
• Ensure regulatory documentation and evidence are complete and auditable.
• Mentor project managers and drive continuous improvement.

Conhecimentos

Project management

Stakeholder management

Regulatory knowledge

Risk management

Budgeting & forecasting

Client leadership

Formação académica

Tertiary qualification in engineering/science/industrial design/project management

Descrição da oferta de emprego

Capgemini Engineering in Australia seeks a Senior Project Manager to lead technically complex, regulated medical device development programs. You will direct multidisciplinary teams and engage directly with senior client stakeholders to shape products from concept through design transfer.

You will apply QMS and project governance, manage scope, cost and risk, and ensure development evidence is complete for regulatory submission, while mentoring peers and contributing to continuous improvement.