We are a young and international team on a mission to change the world for millions around the globe by providing new, faster and reliable diagnostics. Ready to join Nostics?
We are Nostics
Vacancies
Project Leader
📍 Location: Amsterdam
🕒 Timing: As soon as possible
💼 Full-time
About Nostics
At Nostics, we’re building smarter, faster diagnostics for a healthier future. As a growing startup, we combine cutting-edge science with user-friendly technology to ensure accessible diagnostics are available when and where they are needed most.
The Role
We are seeking an experienced Project Leader to drive the development of an In Vitro Medical Diagnostic (IVD) device for infectious diseases. In this role, you will take ownership of the project across development, verification, validation, and regulatory submission readiness.
We’re looking for a pragmatic, hands-on project leader who enjoys being close to the technical work. You are comfortable operating in a startup environment, switching naturally between high-level planning and diving into details with engineers, quality, and external partners to keep progress moving. You combine structure and decisiveness with a practical mindset, and you know how to apply regulatory requirements without slowing development unnecessarily.
The product consists of a diagnostic instrument, disposable cartridge, and software, and is developed together with multiple external partners and an internal, multidisciplinary team. Development activities have started, both internally and in collaboration with external partners. The scope of the role spans product development through verification and validation, and continues into the project management of the clinical studies that follow the V&V phase for both IVDR and FDA pathways. This role is critical in ensuring that the product is delivered compliantly, on time, and ready for regulatory approval and market entry.
Responsibilities
As Project Leader, you will:
- Own and coordinate development activities for a regulated IVD system (instrument, consumables, and software)
- Define, drive, and oversee verification and validation (V&V) planning and execution across hardware, consumables, and software
- Work hands-on with engineering, quality, and external partners to resolve technical, quality, and regulatory challenges
- Align internal teams and external partners on scope, timelines, risks, and deliverables
- Develop and maintain detailed project plans, milestones, and budgets for the development phase
- Ensure compliant execution in line with IVDR, ISO 13485, and FDA design control requirements
- Actively support risk management activities, design changes, and design transfer readiness
- Contribute to the preparation and execution of IVDR and/or FDA regulatory submissions
- Communicate project progress, risks, and financial status to senior management
- Lead the project management of clinical studies following the V&V phase for both IVDR and FDA pathways, coordinating internal teams, CROs, clinical partners, and other stakeholders
Requirements
What we’d love you to bring:
- A completed MSc or PhD in Biomedical Engineering, Life Sciences, Engineering, or a related field
- Extensive experience (typically 8–10+ years) in project management or technical leadership within IVD or regulated medical devices
- Direct involvement in at least one successful IVDR and/or FDA submission is strongly preferred
- Proven experience in regulated medical device development, including verification, validation, and regulatory readiness
- Hands-on experience with regulated development of diagnostic instruments, disposable cartridges or consumables, and software
- Practical working knowledge of IVDR, ISO 13485, and FDA design control requirements, applied in real development environments
- Experience working with external development partners, suppliers, and testing laboratories
- Strong organizational, communication, and stakeholder management skills
- Fluency in English (Dutch is a plus)
- Formal project management accreditation (e.g. PMP, PRINCE2, or equivalent) is preferred
What we offer
- A senior, high-impact role in an ambitious health-tech startup
- The opportunity to bring a complex diagnostic product across the regulatory finish line
- A collaborative and international working environment in Amsterdam
- Competitive salary and benefits, aligned with experience
- A high level of responsibility, ownership, and influence within the organization
Why Join Nostics?
A job with a purpose, and a team driven to make a real impact in diagnostics. Join a fast-moving team that values innovation, integrity, and doing things right.
Interested?
If you have successfully guided an IVD product through development and regulatory submission and enjoy a hands-on role at the heart of product development, we would like to hear from you.
Internship: Microfluidics Simulations (CFD)
We are looking for an intern to support the development of microfluidic systems at Nostics. In this project you will use computational fluid dynamics (CFD) to simulate and evaluate our microfluidic designs, and to connect simulation results to experimental work.
Nostics develops a microfluidic cartridge for rapid point-of-care diagnosis of infectious diseases. The work in this internship contributes directly to ongoing product development.
If you’re pragmatic, inventive, and thrive in a fast-moving start-up environment, you’ll have the opportunity to make a direct impact on technology with global health relevance.
What You’ll Do
- Set up and develop a practical framework for CFD simulations of our microfluidic chips.
- Run and compare simulations for new and existing microfluidic design concepts.
- Help interpret experimental data using simulation insights (e.g., flow fields, particle paths, pressure drops).
- Document your methods and results so others in the team can use them.
- You are an MSc student in (applied) physics, mechanical engineering, biomedical engineering, or a related field.
- You have a basic theoretical background in fluid dynamics.
- You are comfortable programming in Python.
- You are interested in in-vitro diagnostics and applied research.
Why Join Us
- Play a key role in building technology that will directly improve global healthcare.
- Be part of an early-stage team where your ideas and expertise have immediate impact.
- Work at the intersection of optics, biotech, and data science.
- Enjoy the agility and ownership that comes with a fast-growing start-up.
📍 Location: Amsterdam
🕒 Timing: As soon as possible, 6-9 months internship
💼 Full-time
Diverse workforce
Nostics is committed to recruiting and retaining a diverse workforce, and we look for candidates who have a high level of demonstrated comfort with cultural competency. People of color, people with disabilities, women, and lesbian, gay, bisexual, and transgender people are encouraged to apply. All applicants will be considered without regard to race, color, national origin, religion, sexual orientation, sex, marital or parental status, disability, gender identity or expression, age, or any other basis prohibited by law.
Office and lab-accessibility
We are based on the 5th floor but this is accessible by elevator straight from the car-park. The office and lab are equal-floors accessible without stairs, steps or other hurdles. In case you have questions regarding accessibility please give us a call or ask us during the interview process.
Commuting to work
We have only a few parking spots available and we have a train station on a couple minutes walking distance. Commuting by car is possible but public transport is highly prefered.
