Medical Device Engineering Assessment Specialist

ixolabs.ai; France; Hybride; EUR 108 000 - 180 000; Plein temps

Résumé du poste

IXO is seeking professionals to evaluate biomedical-engineering judgments that connect device design to verification evidence. You will assess designs, create expert demonstrations of design controls, and evaluate regulatory-submission content against applicable standards.

Remote assignments are available; hourly rates range and are confirmed before work starts. Prior experience and clear technical writing are required.

Qualifications

• A biomedical or related engineering degree and at least two professional years in biomedical engineering or medical devices, with clear technical writing.

Responsabilités

• Assess medical-device designs and analyses in relevant biomechanics, biomaterials, imaging or instrumentation specialties.
• Create expert demonstrations of design controls and verification/validation workflows.
• Evaluate technical and regulatory-submission content against biomedical standards, explaining gaps in evidence or engineering reasoning.

Connaissances

Biomedical engineering

Technical writing

Formation

Biomedical engineering degree or related field

Master's/doctorate preferred

Description du poste

IXO is engaging specialists to evaluate biomedical-engineering judgments that connect device design to verification evidence. Your contribution is technical work: make the reasoning inspectable, identify substantive errors and provide evidence that supports a reliable assessment.

Work you will do

• Assess medical-device designs and analyses in the relevant biomechanics, biomaterials, imaging or instrumentation specialty.
• Create expert demonstrations of design controls and verification or validation workflows.
• Evaluate technical and regulatory-submission content against applicable biomedical standards, explaining gaps in evidence or engineering reasoning.

Required background and routes

• A biomedical or related engineering degree and at least two professional years in biomedical engineering or medical devices, with clear technical writing.

Preferred background

• A relevant master's/doctorate; FDA 510(k)/PMA, ISO 13485 or IEC 60601 work; specialist depth in instrumentation, imaging, biomaterials or biomechanics.

Deliverables

• Submit the completed technical artifact or assessment with its supporting evidence, explicit assumptions, reproducible checks where applicable, and concise reasons for each material judgment. Address review findings within the agreed scope.

Location and schedule

• Remote assignments are scheduled by agreement, with no guaranteed weekly volume. IXO confirms the applicable timing before work.

Pay and working terms

$80 • $150/hr USD. The agreed hourly rate, scope, schedule and acceptance criteria are confirmed before work starts. Applying does not guarantee an assignment. Use public, licensed or otherwise authorized material only; do not submit confidential employer information, personal data or restricted research.