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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:

• Plan and manage development projects with typical lead times of 6 months to 1.5 years.

• Develop and maintain project plans, milestones, critical path schedules.

• Define, track, and govern project gates, decision points, and deliverables.

• Manage project risks, dependencies, scope and delivery commitments.

• Ensure projects and activities are properly planned, resourced, tracked, and reported.

SAFe & ART Leadership (RTE role):

• Act as Release Train Engineer (RTE) for the assigned Value Stream / Agile Release Train (ART).

• Lead and coordinate execution within the ART in close collaboration with the product manager, system architect, and business owners.

• Identify, manage, and remove cross-team impediments and dependencies.

• Coordinate and facilitate ART events, incl. PI Planning, System Demos, ART-sync, and Inspect & Adapt.

• Actively manage flow and foster continuous improvement within the ART.

Planning, Forecasting & Capacity:

• Develop, maintain and refine realistic plans, forecasts, and capacity-based delivery commitments.

• Align project plans with roadmaps, PI-level execution and team capacity.

• Support capacity & demand planning across development and sustaining work.

• Provide delivery forecasts, scenarios, and trade-off options to stakeholders and PSG.

Regulatory & Quality Integration:

• Ensure projects are executed in compliance with applicable standards, regulations and QMS.

• Collaborate with RA to develop and execute RA strategies and submissions (e.g. 510(k), CE).

• Integrate Design Controls, Risk Management, and DDF/DHF deliverables into plans.

• Support design reviews, stage-gate reviews, audits, and regulatory readiness.

• Maintain traceability between project plans, SAFe artifacts, and regulated documentation.

Stakeholder & Communication Management:

• Serve as the primary point of contact regarding project execution and progress.

• Provide clear, accurate, and timely status reporting to management and PSG.

• Ensure transparency of progress, risks, decisions, and escalations.

• Manage communication and expectations with key stakeholders.

Accountable for:

• End-to-end project execution, including planning, coordination, and completion against PSG agreed scope, timelines and budgets.

• Ensuring predictable and compliant delivery of projects and product lifecycle activities.

• Transparent and timely reporting of project health and ART execution metrics.

• Capacity-aligned project budget forecasting, tracking, and proactive variance management.

Authorities

Authorized to:

• Establish and maintain project plans and ART delivery schedules.

• Facilitate ART events and apply approved governance and ways of working.

• Prepare and submit decision-ready project proposals for review and approval by PSG.

• Implement PSG-approved changes to scope, budget and timelines.

• Escalate delivery risks, deviations, and decision topics in line with QMS and management governance.

• 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:

• 10+ years of experience in project or program management, preferably in medical devices.

• Proven track record of delivering complex, cross functional projects involving hardware and software.

• Experience acting as Release Train Engineer or equivalent.

• Experience with MS Projects, Jira, Big Picture, Planview, or similar tools.

• Strong understanding of medical device development and regulatory frameworks.

• Financial acumen, including budget management and ROI analysis.

• Knowledge of RA requirements and processes related to MDR/CE and FDA/510(k).

Preferred Qualifications:

• PMP or PRINCE2 certification

• SAFe certification (RTE, SA, or SPC)

Personal Attributes, Skills & Competencies:

• Accountable, structured, and delivery-focused

• Strong facilitator and communicator

• Clear and concise written and verbal communication, in English and preferably also in Dutch.

• Able to manage complexity, dependencies, and trade-offs

• Comfortable balancing agility with regulatory rigor in a hybrid SAFe/Agile stage-gate environment.

• Solid understanding of capacity & demand planning and forecasting

• Accurate, result driven, stress-resistant, and able to deal with ambiguity.

• Mindset of collaboration and continuous improvement, even when a topic is of less interest to you.

• Proactive attitude; self-starting in recognizing opportunities and realizing improvements.