Validation & Verification Engineer

TN United Kingdom; Greater London; On-site; GBP 40,000 - 80,000; Full time

Job summary

An established industry player seeks a talented individual to oversee design verification and validation processes for medical devices. This role involves ensuring compliance with stringent regulations and managing the design history file. You will lead design reviews, coordinate clinical trials, and analyze test data to ensure product excellence. Join a forward-thinking company that values innovation and quality, and contribute to the development of life-changing medical products that adhere to the highest standards. This is an exciting opportunity to make a significant impact in the medical field.

Qualifications

• Experience in overseeing design outputs and compliance with regulations.
• Strong background in managing design verification and validation processes.

Responsibilities

• Lead design reviews and verification testing for medical devices.
• Coordinate clinical trials and maintain regulatory documentation.

Skills

Design Verification

Regulatory Compliance

Technical Drawings

Change Control Procedures

Data Analysis

Education

Bachelor's Degree in Engineering or Related Field

Certification in Regulatory Affairs

Tools

Design History File Management

Technical File Compilation

Job description

Job Description

Job overview

:

1. Oversight of completion of design outputs, including technical drawings, product, and component specifications.
2. Oversight of the completion of labelling and packaging design in alignment with relevant medical device and pharma labelling standards and regulations.
3. Lead the design reviews for the device, ensuring the product design is evaluated against requirements detailed within the TRS and URS.
4. Lead the design verification testing of the device and associated labelling and packaging.
5. Coordinate the supply of raw materials for the manufacture of DV samples.
6. Ensure test methods are documented, validated, and staff are trained (training is recorded).
7. Develop the design verification protocol, including traceability to the TRS and test reports.
8. Coordinate internal and external testing in accordance with the protocol.
9. Analyze test data and prepare a design verification report.
10. Lead the design validation of the device, including clinical trials.
11. Coordinate with the CRO, including the documentation and evidence required for the clinical trial.
12. Maintain the design history file in accordance with 21 CFR part 820 requirements.
13. Manage product change control procedures as per CLCC guidelines.
14. Maintain the Device Master Record in accordance with 21 CFR part 820 requirements.
15. Regulatory
16. Collate the Technical File according to relevant regulations (UK, EU, and/or US).

Please apply right away to be considered for this great opportunity.