Clinical Specialist
Manchester, CT - USA
Job Summary
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 builders 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.
Required Experience:
Manager
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more