🚨 Hiring: Validation SME – Medical Device (Design Validation & Remediation)

We are actively seeking an experienced Validation Subject Matter Expert (SME) to support design validation, gap assessments, and remediation activities for medical device programs.

🔍 Key Responsibilities:

✔️ Perform gap assessments of validation plans, protocols, and evidence linking Design Inputs to User Needs

✔️ Develop and enhance validation strategies, including simulated-use and human factors testing

✔️ Review validation results and ensure alignment with risk management and design outputs

✔️ Collaborate with Clinical & Pre-Clinical SMEs for integrated validation evidence

✔️ Support regulatory justification and Design Transfer documentation

🎯 Required Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Human Factors, or related field

• Strong experience in medical device design validation

• Hands-on knowledge of ISO 13485 and 21 CFR Part 820

• Expertise in usability engineering (IEC 62366) and statistical validation methods

• Proven experience in validation gap remediation for DHF projects

• Strong understanding of risk-based validation and human factors validation