Description

Accomplished professional with extensive experience in the medical technologies industry, specializing in medical devices, software engineering, quality assurance, and regulatory compliance. Proven track record in leading product development, managing complex projects, and ensuring adherence to industry standards and regulations. Strong background in hardware and software engineering, quality management systems, and stakeholder collaboration. Dedicated to driving innovation and excellence in the healthcare sector.

Languages

Dutch
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Nijmegen (up to 50km)

Microsure
Risk Manager
June 2025 - Today (1 year)
In this role, I was responsible for establishing and securing full compliance with ISO 14971 throughout the product lifecycle.

Key responsibilities & achievements:
• Ensured Class IIa medical devices complied with ISO 14971 and applicable EU MDR requirements
• Maintained a complete risk management process according to ISO 14971
• Managed all documentation from Risk Management Plan to Risk Management Report / Review
• Led and facilitated risk management meetings with cross-functional stakeholders (R&D, QA/RA, engineering, production, clinical)
• Performed risk assessments using various tools and methods, including:
- FMEA
- Hazard analysis
- URRA
• Identified, evaluated, and mitigated risks across design and manufacturing
• Coordinated risk/benefit evaluations and ensured traceability of risks to design requirements, verifications, and controls
• Aligned risk management documentation with technical file
LRQA
auditor
February 2025 - Today (1 year and 4 months)
As a specialized auditor, I conduct independent audits to assess the effectiveness of quality management systems against ISO 9001 and ISO 13485 standards. I analyze business processes, identify risks and non-conformities, and report objective findings to support organizations with certification and process improvement.
L & L BV:
Product Developer
February 2024 - Today (2 years and 4 months)
In this role, I work on the end-to-end development of electronic products, with a strong focus on PCB design, collaboration with R&D, and component sourcing.

Key responsibilities & contributions:
• PCB Design & Manufacturing Preparation
Designed PCBs for production using PADS and KiCad, ensuring manufacturability and compliance with technical requirements.
• New Product Development
Collaborated with the research team to develop new product concepts and translate them into functional electronic designs.
• Schematic Creation
Created new PCB schematics tailored to evolving product specifications and performance goals.
• Component Sourcing & Purchasing
Managed procurement of electronic components, including supplier coordination and cost optimization.
• Obsolete Component Replacement
Identified and replaced obsolete components with suitable alternatives to maintain production continuity.
• Supply Chain Support
Supported sourcing strategies and ensured component availability for development and manufacturing phases.