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We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
Description
The Senior Project Manager / Release Train Engineer (RTE) leads projects and cross-functional product lifecycle activities within a Value Stream. This role combines project management responsibilities with the coordination responsibilities of a Release Train Engineer, to ensure predictable delivery, effective execution, and compliance with QMS and applicable regulatory requirements.
The position operates at a senior level and manages concurrent development projects and product lifecycle activities across approximately 3-4 cross-functional Scrum teams (approximately 20-30 people).
**Responsibilities **
Project & Portfolio Management:
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Plan and manage development projects with typical lead times of 6 months to 1.5 years.
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Develop and maintain project plans, milestones, critical path schedules.
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Define, track, and govern project gates, decision points, and deliverables.
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Manage project risks, dependencies, scope and delivery commitments.
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Ensure projects and activities are properly planned, resourced, tracked, and reported.
SAFe & ART Leadership (RTE role):
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Act as Release Train Engineer (RTE) for the assigned Value Stream / Agile Release Train (ART).
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Lead and coordinate execution within the ART in close collaboration with the product manager, system architect, and business owners.
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Identify, manage, and remove cross-team impediments and dependencies.
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Coordinate and facilitate ART events, incl. PI Planning, System Demos, ART-sync, and Inspect & Adapt.
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Actively manage flow and foster continuous improvement within the ART.
Planning, Forecasting & Capacity:
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Develop, maintain and refine realistic plans, forecasts, and capacity-based delivery commitments.
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Align project plans with roadmaps, PI-level execution and team capacity.
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Support capacity & demand planning across development and sustaining work.
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Provide delivery forecasts, scenarios, and trade-off options to stakeholders and PSG.
Regulatory & Quality Integration:
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Ensure projects are executed in compliance with applicable standards, regulations and QMS.
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Collaborate with RA to develop and execute RA strategies and submissions (e.g. 510(k), CE).
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Integrate Design Controls, Risk Management, and DDF/DHF deliverables into plans.
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Support design reviews, stage-gate reviews, audits, and regulatory readiness.
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Maintain traceability between project plans, SAFe artifacts, and regulated documentation.
Stakeholder & Communication Management:
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Serve as the primary point of contact regarding project execution and progress.
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Provide clear, accurate, and timely status reporting to management and PSG.
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Ensure transparency of progress, risks, decisions, and escalations.
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Manage communication and expectations with key stakeholders.
Accountable for:
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End-to-end project execution, including planning, coordination, and completion against PSG agreed scope, timelines and budgets.
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Ensuring predictable and compliant delivery of projects and product lifecycle activities.
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Transparent and timely reporting of project health and ART execution metrics.
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Capacity-aligned project budget forecasting, tracking, and proactive variance management.
Authorities
Authorized to:
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Establish and maintain project plans and ART delivery schedules.
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Facilitate ART events and apply approved governance and ways of working.
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Prepare and submit decision-ready project proposals for review and approval by PSG.
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Implement PSG-approved changes to scope, budget and timelines.
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Escalate delivery risks, deviations, and decision topics in line with QMS and management governance.
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Make operational decisions required to ensure timely and compliant delivery.
Relevant Knowledge, skills and competencies
Formal Education:
- Make operational decisions required to ensure timely and compliant delivery.
Experience & Knowledge:
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10+ years of experience in project or program management, preferably in medical devices.
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Proven track record of delivering complex, cross functional projects involving hardware and software.
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Experience acting as Release Train Engineer or equivalent.
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Experience with MS Projects, Jira, Big Picture, Planview, or similar tools.
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Strong understanding of medical device development and regulatory frameworks.
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Financial acumen, including budget management and ROI analysis.
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Knowledge of RA requirements and processes related to MDR/CE and FDA/510(k).
Preferred Qualifications:
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PMP or PRINCE2 certification
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SAFe certification (RTE, SA, or SPC)
Personal Attributes, Skills & Competencies:
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Accountable, structured, and delivery-focused
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Strong facilitator and communicator
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Clear and concise written and verbal communication, in English and preferably also in Dutch.
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Able to manage complexity, dependencies, and trade-offs
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Comfortable balancing agility with regulatory rigor in a hybrid SAFe/Agile stage-gate environment.
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Solid understanding of capacity & demand planning and forecasting
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Accurate, result driven, stress-resistant, and able to deal with ambiguity.
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Mindset of collaboration and continuous improvement, even when a topic is of less interest to you.
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Proactive attitude; self-starting in recognizing opportunities and realizing improvements.