Back to Job SearchROLE OVERVIEW
We are currently seeking a remote Validation Subject Matter Expert (SME) – Design Controls Remediation to join a leading company in the medical device industry. This is an exciting opportunity for a specialist with a strong background in validation to play a pivotal role in supporting both ongoing and upcoming client projects, ensuring compliance and excellence in design processes.
As the Validation SME – Design Controls Remediation, you will be instrumental in assessing validation strategies, developing enhancements, and ensuring that testing and evidence linking design inputs to user needs and clinical performance meet rigorous industry standards.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Validation SME – Design Controls Remediation will be varied however the key duties and responsibilities are as follows:
- Assessing gaps in validation plans, protocols, and evidence linking Design Inputs to user needs and clinical performance.
- Developing or updating validation strategies, including simulated-use and human factors testing.
- Reviewing validation results and ensuring traceability to risk management and design outputs.
- Collaborating with Clinical and Pre-Clinical SMEs to integrate validation evidence effectively.
- As the Validation SME, you will provide expert guidance on compliance with industry standards and support continuous improvement initiatives.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Validation SME – Design Controls Remediation we are looking to identify the following on your profile and past history:
- A Degree or higher level in Engineering, Life Sciences, Human Factors, or related field.
- Proven industry experience in medical device design validation under ISO 13485 and 21 CFR 820.
- A working knowledge and practical experience with usability engineering (IEC 62366), statistical validation, and clinical correlation.
WHAT’S IN IT FOR YOU?
This role offers the chance to work with a pioneering company in the medical device sector, supporting innovative projects that impact patient safety and product excellence. You will develop your expertise further within a collaborative, forward-thinking environment that values scientific rigor and compliance. Additionally, the remote nature of this role offers considerable flexibility, allowing for a healthy work-life balance while advancing your career in a truly dynamic industry.
Key Words: Validation / SME / Design Controls Remediation / Medical Device / ISO 13485 / 21 CFR 820 / Usability Engineering / IEC 62366 / Risk Management / Clinical Performance / Human Factors
"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.
