Medical Devices Specialist

Role Overview A part-time contract opportunity to leverage deep medical device industry expertise in building high-fidelity enterprise environments and designing complex, multi-step evaluation tasks that benchmark the capabilities of frontier technology systems.

What You Will Be Doing
• Reconstruct realistic digital workspaces including design history files, regulatory submissions, DHF/DMR documents, risk analysis matrices, validation protocols, and CAPA records mirroring regulated medical device enterprise workflows
• Design multi-step, cross-functional tasks grounded in real-world device programs that require navigating multiple applications, files, and stakeholder scenarios
• Collaborate asynchronously with fellow medical device experts to shape task scope, review scenarios for realism and rigor, and refine evaluation criteria
• Partner with research teams to develop and iterate on task designs and benchmarking frameworks for regulated device workflows
• Contribute directly to frontier research initiatives that shape how next-generation systems are trained and evaluated

Who We Are Looking For
• Substantial full-time experience at a Fortune 500 medical device manufacturer or large Tier-1 contract developer/manufacturer (e.g., Medtronic, Stryker, Boston Scientific, Abbott, J&J MedTech, GE Healthcare)
• Deep background in one or more of: regulatory affairs (510(k), PMA, EU MDR), quality engineering (21 CFR 820, ISO 13485, ISO 14971), R&D/design controls (SaMD a plus), manufacturing/process validation, or clinical affairs/post-market surveillance
• Hands-on experience with tools such as ANSYS Fluent/STAR-CCM+, Siemens Opcenter, Rockwell FactoryTalk, or DocuSign
• Strong analytical and technical writing skills able to translate complex regulated workflows into structured, rigorous task specifications
• Certifications such as RAC, ASQ CQE, CRE, or CBA are a plus

Role Details
Compensation: ~$1,150 $1,450 per completed task (performance bonuses and hourly model available for top performers)
Work Style: Remote

Duration: Part-time contract; ongoing with potential for extension projects may be adjusted based on needs and performanceHow To Apply
• Click Easy Apply to proceed
• Shortlisted candidates will be contacted with next steps