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Hiring: Verification SME – Medical Device (Design Verification & Remediation)
We are seeking an experienced
Verification Subject Matter Expert (SME)
to support
design verification activities, gap assessments, and remediation efforts
for medical device programs.
🔍
Key Responsibilities:
✔️ Conduct gap analysis of verification strategies, protocols, and traceability matrices across subsystems
✔️ Develop/update test methods, acceptance criteria, and statistical sampling plans
✔️ Review and oversee execution of verification activities, resolving discrepancies
✔️ Ensure Design Outputs meet Design Inputs through robust verification processes
✔️ Integrate verification results into
risk management
and
DHF documentation
✔️ Collaborate with cross-functional teams (Validation, Design Transfer, etc.)
🎯
Required Qualifications:
• Bachelor’s degree in Engineering or related field
• Strong experience in
medical device design verification
• Hands-on knowledge of
ISO 13485
and
21 CFR Part 820
• Expertise in
test method development, statistical analysis, and verification reporting
• Experience leading
verification gap assessments and remediation programs
• Strong understanding of
traceability and risk-based verification approaches– Medical Device (Design Verification & Remediation)
We are seeking an experienced
Verification Subject Matter Expert (SME)
to support
design verification activities, gap assessments, and remediation efforts
for medical device programs.
🔍
Key Responsibilities:
✔️ Conduct gap analysis of verification strategies, protocols, and traceability matrices across subsystems
✔️ Develop/update test methods, acceptance criteria, and statistical sampling plans
✔️ Review and oversee execution of verification activities, resolving discrepancies
✔️ Ensure Design Outputs meet Design Inputs through robust verification processes
✔️ Integrate verification results into
risk management
and
DHF documentation
✔️ Collaborate with cross-functional teams (Validation, Design Transfer, etc.)
🎯
Required Qualifications:
• Bachelor’s degree in Engineering or related field
• Strong experience in
medical device design verification
• Hands-on knowledge of
ISO 13485
and
21 CFR Part 820
• Expertise in
test method development, statistical analysis, and verification reporting
• Experience leading
verification gap assessments and remediation programs
• Strong understanding of
traceability and risk-based verification approaches
