Senior Project Manager – Medical Device Development

Job not on LinkedIn

🔥 3 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Capgemini

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1967

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Capgemini is a global leader in partnering with businesses to transform and manage their operations by harnessing the power of technology. With expertise across a wide array of industries such as aerospace, automotive, banking, and healthcare, Capgemini provides a constantly evolving portfolio of services to meet the ever-changing needs of their clients. Their offerings include cloud, cybersecurity, data and artificial intelligence, and enterprise management, among others. Capgemini also emphasizes innovation and sustainability, helping companies achieve digital transformation while promoting environmental and social responsibility. Additionally, Capgemini provides career opportunities across various levels and professions, encouraging innovation and diversity in its workforce.

📋 Description

• 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, provide clear reporting, facilitate decisions and align 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 applicable QMS and project governance frameworks, 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 • Work with multidisciplinary teams and senior client stakeholders on regulated medical device programs from early concept through design transfer

🎯 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 • Practical experience with 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 • Experience communicating 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 • Project or program management certification such as PMP or PRINCE2 is highly regarded • Experience with active, software-enabled, connected, diagnostic, therapeutic, laboratory or clinical-use devices is highly regarded • Familiarity with IEC 62304, IEC 60601, IEC 62366-1, FDA, TGA or EU MDR expectations is highly regarded • Experience preparing or supporting regulatory submissions, technical documentation, clinical or usability activities, supplier qualification, CAPA or audits is highly regarded • Consultancy experience across parallel client engagements, proposals, commercial variations and fixed-price or milestone-based delivery is highly regarded • Experience mentoring project managers and improving delivery systems, templates and governance practices is highly regarded

🏖️ Benefits

• Flexible work arrangements, including remote work and flexible work hours • Career growth programs • Access to certifications in technologies such as AWS and Microsoft Azure • Opportunities across diverse professions • Healthy work-life balance support