Medical Device Engineer (ID: kswhdCS4)

The Whiteley Clinic is expanding and we’re looking for full and part-time Surgeons and Interventional Radiologists who want to specialise in treating varicose veins and other venous conditions.

Why join our award award-winning team?

• Receive full training in The Whiteley Protocol
• Ongoing support & training and Back-Office services will be provided
• Become a member of The College of Phlebology
• Access to the Venous Registry
• Excellent results and patient satisfaction
• Positions available in current clinic locations with new locations opening in 2024

We are seeking a highly skilled and detail-oriented medical device engineer to join our team. As a medical device engineer, your primary responsibility will be to complete the design controls for our Quality Management System (QMS) and develop the necessary technical documentation for obtaining CE, FDA, and UKCA approvals for our products. You will play a critical role in ensuring regulatory compliance and product quality throughout the design and approval process.
Please Note: A minimum of 5 years experience within a medical device engineering design team is required.

This role will be hybrid working with a weekly meeting at our Guildford Clinic

Salary £35,000

Responsibilities:

SOP, Templates, Forms, Plans and Reports for:

• Design Input, Design Output Design review, Design transfer, Design Verification and Validation, Design History File, Device Master Record and Design Master File.
• Documents Required for each category:
• SOPs – 9 , Forms – 9, Templates – 9, Plan product specific – 9 and Report product specific – 9.
• Design Controls: Lead and oversee the implementation of design controls within the Quality Management System.
•  Regulatory Compliance: Stay up-to-date with the latest regulations and guidelines from regulatory bodies such as CE, FDA, and UKCA, ensuring adherence to applicable requirements.
• Documentation Preparation: Develop and manage technical documentation required for CE, FDA, and UKCA approval, including but not limited to Design History Files (DHF) and Technical Files (TF).
• Risk Assessment: Conduct thorough risk assessments, including Hazard Analysis and Risk Management, and ensure appropriate risk mitigation strategies are implemented throughout the design and development process.
• Standards Compliance: Ensure compliance with relevant international standards such as ISO 13485, ISO 14971, IEC 60601, and any other applicable standards.
• Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Manufacturing, to gather necessary information and provide guidance on regulatory requirements.
• Audits and Inspections: Support internal and external audits, inspections, and regulatory assessments, ensuring compliance with applicable regulations and standards.
• Training and Guidance: Provide training and guidance to internal stakeholders on regulatory requirements and best practices related to design controls and approval documentation.