Hire Vetted Specialists
Hire a Medical Device Engineer
For medical device work you need engineers who have shipped under design controls — not generalists learning IEC 60601 on your budget. Talent Badger's bench includes medical device EEs, firmware engineers, and regulatory specialists with FDA 510(k), IEC 60601, ISO 13485, and V&V experience, available fractionally with NDA and IP assignment from day one.
The work these specialists own
- Design-to-standard electronics and firmware: IEC 60601-1/-1-2 from the first schematic, not retrofitted before submission.
- V&V planning and execution: protocols, traceability, and reports that survive an auditor.
- Regulatory support: 510(k) strategy, design history files, risk management under ISO 14971.
- Device categories on the bench: neurostimulation, patient monitoring, imaging and diagnostics, respiratory, IVD, connected/RPM devices.
Why fractional works for medtech
- Regulated-device expertise is needed intensely at specific phases — architecture, V&V, submission — not uniformly for years.
- A specialist who has been through submissions de-risks the schedule more than an extra full-time generalist.
- Milestone-gated engagements map naturally onto design-control stage gates.
Common questions
Yes — the bench includes engineers and regulatory specialists who have taken devices through 510(k) clearance and operated inside ISO 13485 quality systems, including design controls, CAPA, and audit response.