- Location
- Manchester, NH
- Type
- Full-time
- Department
- Healthcare
- Education
- Master
- Closing date
- Today
- Source
- ApplyToJob
Description
DEKA R&D, on behalf of a partner organization, is looking for a Clinical Specialist to support one of our medical device projects as it moves toward clinical use.
We are bringing POD, a normothermic machine perfusion device that functionally characterizes deceased-donor kidneys, out of development and into the world. The device was engineered over ~6 years by the DEKA R&D team in Manchester, NH, where essentially all hands-on device expertise sits today. This hire creates our own capability to run and teach the device, independent of DEKA R&D: someone who masters POD alongside the engineers, then delivers direct perfusion in the lab and trains the external users, clinical sites, and trial personnel who will run it — guaranteeing standardized output regardless of site or operator. It is our first clinical/field hire and a builder’s role: their practice becomes the standard everyone else is trained against.
How you will make an impact:
We are bringing POD, a normothermic machine perfusion device that functionally characterizes deceased-donor kidneys, out of development and into the world. The device was engineered over ~6 years by the DEKA R&D team in Manchester, NH, where essentially all hands-on device expertise sits today. This hire creates our own capability to run and teach the device, independent of DEKA R&D: someone who masters POD alongside the engineers, then delivers direct perfusion in the lab and trains the external users, clinical sites, and trial personnel who will run it — guaranteeing standardized output regardless of site or operator. It is our first clinical/field hire and a builder’s role: their practice becomes the standard everyone else is trained against.
How you will make an impact:
- Master & own the device. Embed with the DEKA team to reach engineering-grade competence, then run POD routinely without R&D present; stay the clean conduit for configuration changes in and field observations out.
- Deliver direct perfusion. Personally perform POD perfusion/assessment runs in preclinical and partner-lab settings to a consistent, documented standard; own run setup, troubleshooting, integrity, and deviation records.
- Train & certify external users. Build and own the operator-qualification/training package (the pre-A2 training commitment); train and certify external perfusionists, technicians, and clinical staff; proctor early cases, then step down to as-needed support.
- Enable clinical-trial sites. Support lead-in and pivotal site activation, protocol execution, clean at-source data capture, and site-to-site standardization; support DSMB and clinical-events documentation.
- Hold the claim firewall. POD states deviation, never suitability — no “suitable/unsuitable” coaching, no comparative or composite language. A regulatory boundary, not a preference.
- Clinical + organ background. An RN with deep transplant experience (transplant or organ-donation coordinator; CCTC a plus), or a clinical perfusionist / organ-preservation specialist — with the aptitude to become the authority on a novel perfusion device.
- Ex-vivo perfusion device or MCS/ECMO experience. Hands-on with ex-vivo organ perfusion devices — EVLP, kidney/liver assist, organ transport, or similar; comfortable operating, troubleshooting, and teaching complex clinical hardware.
- Medical-device field experience. Prior Clinical / Field Specialist (or Thought-Leader-Liaison) work supporting FDA device studies, coordinating pre-clinical studies, and educating study sites — with strong trainer and KOL-facing credibility.
- Field-ready. Manchester, NH based with 20% travel to NYC. GCP / IDE exposure preferred; disciplined documentation; calm judgment under time-critical runs.
Skills
GCPFDA
