Senior System Engineer

Senior Systems Engineer – MedTech (Freelance / Consultancy)

Central Netherlands – remote, with ~1 day per week on site

November 2026 start | 2 days per week, growing with the project | Option to move to payroll later

About our client

Our client is an innovative MedTech start-up developing a first-in-class, disposable device for real-time blood flow monitoring in interventional cardiology. Their first product is a Class IIa active medical device combining a novel sensor, embedded electronics and software. It will form the foundation of a broader technology platform.

They are now looking for a Senior Systems Engineer to connect all the technical and regulatory building blocks and help bring this product, and the platform behind it, to market.

The role

You will be the technical linking pin between the product development partner, the regulatory/quality partner, the manufacturing partner, key suppliers and the internal leadership team. Your job is to make sure every element of the design fits together as one coherent, compliant system: from requirements and risks through integration, verification, validation and the technical dossier.

This is an independent, hands-on role reporting to the CTO (technical content) and COO (operations and quality).

Key responsibilities

• Integrate the sensor, embedded electronics, firmware/software and mechanical components into one robust system
• Own end-to-end traceability (requirements ↔ risks ↔ design ↔ tests) in line with FDA and MDR expectations
• Coordinate interfaces and handovers between development, manufacturing and supplier partners; review and challenge partner deliverables from a system perspective
• Align system design with MDR and FDA requirements together with the regulatory partner, and contribute to the technical file and 510(k)/CE submissions
• Make sure design control runs in line with ISO 13485, ISO 14971, IEC 62304, the IEC 60601 family, IEC 62366-1 and ISO 10993
• Shape the system-level V&V strategy and review protocols and test reports
• Support manufacturing partner selection, DfM/DfA and transfer to manufacturing
• Support clinical studies, including a diagnostic accuracy study
• Run day-to-day technical planning and co-lead design reviews

What you bring

• A BSc or MSc in Electrical, Biomedical or Systems Engineering, Mechatronics, Physics or a similar field
• Around 10 years of experience in the medical device industry, ideally including start-up or scale-up environments
• A strong track record as a systems engineer or system architect on complex active medical devices (Class IIa or higher)
• Hands-on experience contributing to MDR technical documentation and FDA submissions (e.g. 510(k)); FDA Class II experience is a plus
• Comfort working where sensor technology, electronics and software meet
• Solid knowledge of systems engineering practice: V-model, requirements management, V&V and configuration management
• Proven ability to coordinate several external partners and suppliers
• Excellent communication skills: you can translate between engineers, clinicians, regulators and business stakeholders
• Fluent English; Dutch is a plus
• Based in, or able to travel easily to, central Netherlands for about one day per week on site

What’s on offer

• The chance to shape a first-in-class device in interventional cardiology and the technology platform behind it
• A key role in a small, highly experienced core team, working closely with the COO and CTO
• A flexible consultancy engagement: start at 2 days per week (easy to combine with other assignments), growing with the project through 2027
• The option to move to a payroll position at a later stage
• A competitive, flexible hourly rate

Interested?

Apply via this advert.