Lead Systems Engineer - MBSE & Regulated Medical Devices

Amaris Consulting | Part of Mantu; Drachten; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amaris Consulting | Part of Mantu seeks a Lead Systems Engineer to coordinate multidisciplinary projects across mechanical, electrical, software, and physics teams in the Netherlands.

You will translate high-level needs into structured requirements, maintain full traceability through the V-model, and support decision-making on risks and design trade-offs. Travel within the Netherlands and occasional international travel are expected.

Qualifications

• MSc degree in Systems Engineering or related field.
• More than 3 years of experience in a lead engineering role across multiple technical domains.
• Experience in medical, consumer, optical, or complex technology products.
• Strong knowledge of systems engineering methods: requirements analysis, architecture development, design reviews, and V-model processes.
• Experience maintaining requirements traceability from system-level needs to design, verification, and validation.
• Familiarity with regulatory design controls and quality requirements (FDA, ISO 13485, EU MDR).
• Proficiency with modelling/simulation tools (Creo/Ansys/Matlab/Cameo).
• Experience with requirements-management tools (IBM DOORS or similar).
• Strong data and statistical analysis skills; Design for Six Sigma certification.
• Excellent communication and collaboration with international teams and suppliers.

Responsibilities

• Lead systems engineering activities across multidisciplinary development projects.
• Translate high-level product needs into structured system requirements and verification plans.
• Maintain end-to-end traceability throughout the V-model.
• Assess system dependencies, design trade-offs, risks, and constraints to support decisions.
• Coordinate specialist engineering teams to achieve system-level objectives.
• Apply established development processes within a regulated product environment.
• Contribute to continuous improvement of systems engineering practices (Model-Based systems engineering, SAFe).
• Collaborate with internal partners and external suppliers; travel within the Netherlands and internationally.

Skills

Systems engineering

Requirements management

Traceability

Regulatory compliance

Data analysis

Communication

Cross-border collaboration

Education

MSc in Systems Engineering

Tools

Creo

Ansys

Matlab

Cameo

IBM DOORS

Job description

Amaris Consulting | Part of Mantu seeks a Lead Systems Engineer to coordinate multidisciplinary projects across mechanical, electrical, software, and physics teams in the Netherlands.

You will translate high-level needs into structured requirements, maintain full traceability through the V-model, and support decision-making on risks and design trade-offs. Travel within the Netherlands and occasional international travel are expected.