Back to Job SearchROLE OVERVIEW
We are currently looking for a remote Validation SME – Design Controls Remediation to join a leading company in the medical device industry based in the US. As the Validation SME – Design Controls Remediation, you will play a pivotal role in supporting ongoing and upcoming project and client activity.
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:
1. Assessing gaps in validation plans, protocols, and evidence linking Design Inputs to user needs and clinical performance.
2. Developing or updating validation strategies, including simulated-use and human factors testing.
3. Reviewing validation results and ensuring traceability to risk management and design outputs.
4. Collaborating with Clinical and Pre-Clinical SMEs for integrated validation evidence.
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:
1. Relevant degree in Engineering, Life Sciences, Human Factors, or related field.
2. Proven industry experience in medical device design validation under ISO 13485 and 21 CFR 820.
3. A working knowledge and practical experience with usability engineering (IEC 62366), statistical validation, and clinical correlation.
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 Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
We are currently looking for a remote Validation SME – Design Controls Remediation to join a leading company in the medical device industry based in the US. As the Validation SME – Design Controls Remediation, you will play a pivotal role in supporting ongoing and upcoming project and client activity.
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:
1. Assessing gaps in validation plans, protocols, and evidence linking Design Inputs to user needs and clinical performance.
2. Developing or updating validation strategies, including simulated-use and human factors testing.
3. Reviewing validation results and ensuring traceability to risk management and design outputs.
4. Collaborating with Clinical and Pre-Clinical SMEs for integrated validation evidence.
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:
1. Relevant degree in Engineering, Life Sciences, Human Factors, or related field.
2. Proven industry experience in medical device design validation under ISO 13485 and 21 CFR 820.
3. A working knowledge and practical experience with usability engineering (IEC 62366), statistical validation, and clinical correlation.
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 Life Science 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.
Your Recruitment Consultant
Share this Job
