{"id":2495654,"url":"https://alion.io/job/capgemini-senior-project-manager-medical-device-development","title":"Senior Project Manager -Medical Device Development","company":{"id":145,"name":"Capgemini","domain":"capgemini.com","url":"https://alion.io/company/capgemini","size_band":"5000+","is_staffing_agency":false,"employer_type":"services","is_intermediary":false,"listed_via":null,"ats_vendor":"Career site","truth_index":{"grade":"B","score":80,"open_postings":1850,"ghost_share":0.001,"stale_share":0.8,"repost_share":0.009,"time_to_fill_p50_days":28,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sydney, Australia"],"countries":["AU"],"hiring_countries":["AU"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":67000,"max_usd":119000,"period":"year","method":"role_seniority_country_cell","sample_n":8},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AWS","optional":false},{"name":"Azure","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"IEC 60601","optional":false},{"name":"IEC 62304","optional":false},{"name":"IEC 62366","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-14T00:36:23Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-29T07:49:25Z","board_verified":true,"closed_at":null,"days_open":15,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":15},"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.\nYour role\nIn 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.\nWe 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.\nWorking 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.\nYou will play a key role in:\n\nLead medical device programs through discovery, feasibility, requirements, design development, prototyping, verification, validation, design transfer and production readiness. \nCreate and maintain integrated project plans covering scope, deliverables, work breakdown, schedule, budget, resourcing, dependencies, stage gates, quality activities and decision criteria. \nAct as the primary client interface for delivery, providing clear reporting, facilitating decisions and aligning technical work with contractual, commercial, regulatory and business objectives. \nLead multidisciplinary teams, define accountabilities, coordinate internal and external contributors, remove delivery constraints and maintain effective operating rhythms. \nApply 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. \nPlan and facilitate project kick-offs, technical reviews, design reviews, end-of-phase reviews and governance forums; record decisions, actions, approvals and objective evidence. \nOwn project risk, issue, assumption and dependency management, including escalation, mitigation planning and closure tracking. \nManage project finances, estimates, forecasts, purchasing inputs, supplier commitments, variations and scope changes; protect delivery margin while maintaining quality and client outcomes. \nCoordinate prototype and pilot builds, supplier engagement, test readiness, verification and validation execution, nonconformity resolution and design transfer activities. \nEnsure 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. \nGuide teams in balancing safety, usability, technical performance, manufacturability, serviceability, regulatory needs, cost and schedule. \nSupport proposals, project scoping, delivery estimates and client workshops, and contribute to continuous improvement of project and medical device development practices. \nYour profile\nSubstantial experience leading end-to-end medical device or similarly regulated product development programs in a consultancy, manufacturer or technology business. \nDemonstrated delivery of complex electromechanical products involving multiple engineering disciplines, suppliers and manufacturing partners. \nWorking knowledge of ISO 13485 design controls and ISO 14971 risk management, with practical experience of requirements, traceability, design reviews, verification, validation and design transfer. \nStrong project controls capability across planning, scheduling, resource management, budget control, forecasting, risk, change and executive reporting. \nAbility to translate ambiguous commercial, user, technical and regulatory inputs into an executable development plan and clear team priorities. \nCredible client leadership, negotiation and facilitation skills, including the ability to communicate with executives, technical specialists, quality and regulatory stakeholders. \nExperience managing controlled documentation, review and approval workflows, action registers, decision logs and development records within a QMS. \nPractical understanding of product development, prototyping, test planning, supplier engagement, manufacturing processes and production transfer. \nTertiary qualification in engineering, science, industrial design, project management or a related discipline, or equivalent relevant experience. \nHighly regarded \nProject or program management certification such as PMP, PRINCE2 or equivalent demonstrated practice. \nExperience with active, software-enabled, connected, diagnostic, therapeutic, laboratory or clinical-use devices. \nFamiliarity with IEC 62304, IEC 60601, IEC 62366-1, FDA, TGA or EU MDR expectations relevant to the programs led. \nExperience preparing or supporting regulatory submissions, technical documentation, clinical or usability activities, supplier qualification, CAPA or audits. \nConsultancy experience across parallel client engagements, proposals, commercial variations and fixed-price or milestone-based delivery. \nExperience mentoring project managers and improving delivery systems, templates and governance practices\nWhat you’ll love about working here\nWe 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.\nAt the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.\nEquip yourself with valuable certifications in the latest technologies such as AWS and Microsoft Azure.\nCapgemini 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","description_format":"text","description_chars":7245,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[{"name":"Australia","iso":"AU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health & Medical Electronics","Systems Integrators","Management Consulting","Engineering Services"],"lifecycle":[{"event":"open","at":"2026-10-14T04:16:01Z"}],"visa":[],"liveness":{"score":55,"band":"ok","label":"Likely open","p_open":1,"p_active":0.608,"p_room":0.9,"age_days":15,"expected_fill_days":28,"reasons":["conf:2","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/capgemini-senior-project-manager-medical-device-development","json_url":"https://alion.io/job/capgemini-senior-project-manager-medical-device-development.json","meta":{"generated_at":"2026-10-29T11:11:56Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":16923,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":145},"rest":"https://alion.io/mcp/rest/get_company?id=145"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcapgemini-senior-project-manager-medical-device-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcapgemini-senior-project-manager-medical-device-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcapgemini-senior-project-manager-medical-device-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/capgemini-senior-project-manager-medical-device-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcapgemini-senior-project-manager-medical-device-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2495654}},{"tool":"search_jobs","arguments":{"company":"capgemini.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2495654},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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