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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:

• 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.