Remote Senior Medical Device Program Lead

Capgemini; Sydney; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

Capgemini Engineering is seeking a Senior Project Manager to lead regulated medical device development programmes from concept through to design transfer and production readiness.

You will direct technically complex projects, work with multidisciplinary teams, and engage directly with senior client stakeholders to ensure compliant, timely delivery and robust project controls across scope, cost and schedule.

Qualifications

• Substantial experience leading end‑to‑end medical device development programmes in a consultancy, manufacturer or tech business.
• Delivery of complex electromechanical products involving multiple disciplines, suppliers and manufacturing partners.
• Working knowledge of ISO 13485 design controls and ISO 14971 risk management, including requirements, traceability and design transfer.
• Strong project controls across planning, scheduling, budget, forecasting and executive reporting.
• Ability to translate ambiguous inputs into executable development plans and clear priorities.

Responsibilities

• Lead medical device programmes from discovery to production readiness with cross‑functional teams.
• Create integrated project plans covering scope, schedule, budget and resources.
• Interface with senior clients, provide clear reporting and align work with commercial and regulatory objectives.
• Apply QMS and regulatory governance, including design reviews, verification and validation.
• Manage risks, issues, assumptions and dependencies; drive decisions and actions to closure.
• Coordinate design transfer activities, supplier engagement and production readiness activities.

Skills

Project leadership

Regulated development

ISO 13485 knowledge

Risk management

QMS processes

Client leadership

Cross-disciplinary teamwork

Design transfer

Education

Engineering degree

Job description

Capgemini Engineering is seeking a Senior Project Manager to lead regulated medical device development programmes from concept through to design transfer and production readiness.

You will direct technically complex projects, work with multidisciplinary teams, and engage directly with senior client stakeholders to ensure compliant, timely delivery and robust project controls across scope, cost and schedule.