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DEKA Research & Development
Clinical SpecialistDEKA Research & Development • Manchester, NH, US
Clinical Specialist

Clinical Specialist

DEKA Research & Development • Manchester, NH, US
23 days ago
Job type
  • Full-time
  • Quick Apply
Job 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:

  • 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.

Who we're looking for:

  • 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.
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Clinical Specialist • Manchester, NH, US

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