Senior Medical Device V&V Engineer (Class IIb/III)

Barrington James; Eindhoven; On-site; EUR 60,000 - 85,000; Full time

Job summary

Barrington James has an opening for an experienced Verification & Validation Engineer to join a medical technology organisation in Eindhoven, Netherlands. You will plan, execute and document V&V activities across a portfolio of Class IIb and Class III devices.

You'll collaborate with R&D, Design Engineering, Quality and Regulatory teams to ensure devices meet design specifications and regulatory standards. Dutch language skills are a plus, but fluent English is required.

Qualifications

• Minimum 3 years' experience in Verification & Validation within the medical device industry.
• Previous experience with Class IIb and/or Class III medical devices.
• Knowledge of EU MDR 2017/745.
• Understanding of ISO 13485 and ISO 14971.
• Experience with risk-based testing and design traceability.
• Fluent English required; Dutch language skills would be advantageous.

Responsibilities

• Develop and maintain V&V protocols, test plans and test reports.
• Perform design verification testing to ensure products meet predefined specifications.
• Support validation activities to demonstrate that devices meet user needs and intended use requirements.
• Conduct functional, mechanical, performance and reliability testing.
• Identify, investigate and document test failures and non-conformances.
• Work closely with Design Engineering and R&D teams to resolve technical issues.
• Ensure all verification and validation documentation meets applicable regulatory requirements.
• Support design control activities and maintain traceability between user needs, design inputs, outputs and verification evidence.

Skills

V&V experience

Risk-based testing

Design traceability

Regulatory awareness

Job description

Barrington James has an opening for an experienced Verification & Validation Engineer to join a medical technology organisation in Eindhoven, Netherlands. You will plan, execute and document V&V activities across a portfolio of Class IIb and Class III devices.

You'll collaborate with R&D, Design Engineering, Quality and Regulatory teams to ensure devices meet design specifications and regulatory standards. Dutch language skills are a plus, but fluent English is required.