Senior Project Manager / RTE

Reposted 23 Days Ago
Be an Early Applicant
Veenendaal, NLD
In-Office
Senior level
Healthtech • Biotech
The Role
The Senior Project Manager / RTE will lead cross-functional teams, ensuring project delivery, compliance with regulatory standards, and effective management of product development activities.
Summary Generated by Built In
Are you a current Elekta employee?  

Please click here to apply through our internal career site Find Jobs - Elekta.

Want to join a team with a mission to improve and save lives?  

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.

Skills Required

  • 10+ years of experience in project or program management, preferably in medical devices
  • Proven track record of delivering complex, cross functional projects
  • Experience acting as Release Train Engineer or equivalent
  • 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)

Elekta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elekta and has not been reviewed or approved by Elekta.

  • Retirement Support A 401(k) with employer match is a prominent benefit, with vesting noted as part of the plan.
  • Leave & Time Off Breadth PTO and paid holidays are included, with PTO accruing from the start and rollover allowed within limits.
  • Healthcare Strength Medical, dental, vision, life and disability coverage are included, complemented by an Employee Assistance Program.

Elekta Insights

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The Company
Atlanta, GA
4,700 Employees
Year Founded: 1972

What We Do

At Elekta, our outcome-driven and cost-efficient solutions provide lasting clinical difference and are developed through sustainable environmental, social and governance practices. We’ve been working openly and proactively with clinicians and our partners for almost half a century to advance precision radiation therapy and meet continuously evolving patient needs—no matter where they are in the world. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in 120 countries and listed on Nasdaq Stockholm.

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