Senior Project Lead

Senior Project Leader IVD Product Development | Amsterdam

Unity Partners is conducting this search exclusively on behalf of a health-tech scale-up based in Amsterdam.

Our client is on a mission to build smarter, faster diagnostics for a healthier future. Their IVD system, consisting of a diagnostic instrument, disposable cartridge, and software, is now transitioning from feasibility into full-scale product development. This is a pivotal moment for the company, and they are looking for a Senior Project Leader to own this phase end-to-end.

This is not a coordination or advisor role. This is a hands-on position at the heart of a complex, regulated product development program, with real impact on timelines, quality, and ultimately, market entry.

Role Overview

As Senior Project Leader, you take full ownership of the development program and drive it from current-stage development through verification, validation, and regulatory submission readiness. You work closely with a system architect who owns the technical architecture. Your role is to translate that into execution: aligning teams, managing dependencies, escalating issues early, and ensuring decisions happen on time.

The majority of development is executed through two external partners. You maintain strong internal ownership and clear oversight across progress, quality, cost, and timelines, while staying close to the technical work yourself.

Development runs through mid-2027, after which the focus shifts to clinical and analytical studies. The ideal candidate stays involved through this transition and contributes to study preparation alongside the scientific and clinical lead.

Key Responsibilities

• Own and coordinate all development activities for the IVD system across instrument, cartridge, and software
• Define, drive, and oversee V&V planning and execution across all system components
• Translate technical architecture into structured project plans, milestones, and budgets
• Align internal teams and external development partners on scope, timelines, risks, and deliverables
• Work hands-on with engineering, quality, and external partners to resolve technical and regulatory challenges
• Ensure compliant execution in line with IVDR, ISO 13485, and FDA design control requirements
• Support risk management, design changes, and design transfer readiness
• Contribute to IVDR and/or FDA regulatory submissions
• Lead the project management of clinical studies following the V&V phase, coordinating CROs, clinical partners, and internal stakeholders
• Report project progress, risks, and financial status to senior management

Your Profile

• MSc or PhD in Biomedical Engineering, Life Sciences, Engineering, or a related field
• 8+ years of experience in project management or technical leadership within IVD or regulated environments like medical devices, pharma or food
• You have done this work yourself, not purely a program manager, but someone who has been close to the technical execution
• Direct involvement in at least one successful IVDR and/or FDA submission is strongly preferred
• Practical working knowledge of IVDR, ISO 13485, and FDA design control requirements
• Experienced in managing external development partners, suppliers, and testing laboratories
• Comfortable in a startup environment, not everything is defined, and you thrive on making it happen
• Strong communicator and stakeholder manager, fluent in English (Dutch is a plus)
• Formal project management certification (PMP, PRINCE2, or equivalent) is preferred

What is on offer

• A senior, high-impact role at a VC-backed startup with a clear and ambitious product roadmap
• The opportunity to bring a complex IVD product across the regulatory finish line
• A small, driven team of around 25 people internally, with short lines, strong ownership culture, and real urgency
• Competitive salary and benefits, aligned with seniority and impact
• Based in Amsterdam, with a collaborative and international team

Interested?

Reach out to Christian Steenkamp via [email protected] | +31 (0)20 8938 606