Verification Validation Engineer

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

Product Classification:

Class IIb & Class III Medical Devices

The Opportunity

Are you an experienced Verification & Validation Engineer looking to take the next step in your medical device career?

We are currently recruiting for a V&V Engineer to join an innovative medical technology organisation based in Eindhoven, Netherlands.

The successful candidate will be responsible for planning, executing and documenting verification and validation activities across a diverse portfolio of Class IIb and Class III medical devices.

Working closely with R&D, Design Engineering, Quality and Regulatory Affairs teams, you will play a key role in ensuring that medical devices meet their design specifications, intended use requirements and applicable regulatory standards.

The organisation operates across several specialist therapy areas, including Cardiology, Orthopaedics, Vascular, Neurology and Surgical Technologies.

Medical Device Portfolio

• Cardiology: Cardiovascular catheters, cardiac implants and stent systems.
• Orthopaedics: Spinal implants, joint replacement systems and orthopaedic devices.
• Vascular: Implantable vascular devices and endovascular technologies.
• Neurology: Neurostimulation systems and implantable neurological devices.
• Surgical Technologies: Advanced surgical instruments and specialist medical devices.

The portfolio includes both Class IIb and Class III medical devices.

Key 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.

Candidate Requirements

• Minimum 3 years' experience in Verification & Validation within the medical device industry.
• Previous experience working 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.
• Familiarity with functional, mechanical and performance testing.
• Fluent English required; Dutch language skills would be advantageous.

Interested in Applying?

If you have at least 3 years' experience in Medical Device Verification & Validation and are interested in working with complex Class IIb and Class III products, we would be keen to hear from you.