Technical Lead – Design History File (DHF)

ROLE OVERVIEW

An exciting opportunity for a Technical Lead – Design History File (DHF) Remediation to join a leading medical device company based in the US. In this role, you will be at the forefront of critical remediation projects, ensuring that all activities align with regulatory standards and best practices within the medical device sector.

This position offers the chance to lead cross-functional teams, drive compliance initiatives, and contribute to impactful projects that uphold the highest quality and regulatory standards across global markets.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Technical Lead – Design History File (DHF) Remediation will be varied however the key duties and responsibilities are as follows:

• Leading the remediation of an assigned Design History File (DHF) across all phases of design controls.
• Coordinating and managing multiple remediation workstreams, including user needs, design inputs/outputs, verification, validation, and design transfer.
• Providing technical leadership and oversight to cross-functional teams, ensuring alignment across engineering, quality, regulatory, and risk management.
• Ensuring remediation deliverables are technically sound, consistent, and compliant with applicable U.S. and global regulatory requirements.
• As the Technical Lead you will ensure all activities adhere to relevant standards and regulatory expectations, fostering a culture of continuous improvement.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Technical Lead – Design History File (DHF) Remediation we are looking to identify the following on your profile and past history:

• A Degree or higher level in a relevant field (e.g., Biomedical Engineering, Life Sciences, Quality Assurance).
• Extensive experience supporting Design History File (DHF) remediation within regulated medical device environments.
• Proven experience leading complex, cross-functional remediation initiatives across multiple design control phases.
• A working knowledge and practical experience with FDA Quality System Regulation (QSR), Quality Management System Regulation (QMSR), and global regulatory frameworks.

WHAT’S IN IT FOR YOU?

• Opportunity to lead vital projects within a globally recognized medical device organisation.
• Development of your leadership skills in a dynamic, compliant environment.
• Chance to make a tangible impact on product compliance and patient safety.
• Competitive compensation package and benefits tailored to your experience.

Key Words: Technical Lead / Design History File / DHF Remediation / Medical Device / FDA QSR / QMSR / Regulatory Compliance / Design Controls / Verification / Validation / Design Transfer

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.