Clinical Specialist

DEKA Research & Development; Manchester (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

DEKA R&D is seeking a Clinical Specialist to support POD device development as it moves toward clinical use. Based in Manchester, NH with 20% travel to NYC, you will master the POD system and run perfusion in labs, then train external users, trial personnel, and sites to ensure standardized output.

You will enable site activation and maintain rigorous documentation and regulatory boundaries. Ideal candidates have clinical transplant experience, ex-vivo perfusion device experience, and prior

Qualifications

• Clinical professional with transplant or organ-donation experience.
• Hands-on perfusion device operation and teaching capability.
• Experience supporting FDA device studies or clinical trials helpful.

Responsibilities

• Master and own POD device; embed with DEKA team for engineering-grade competence.
• Deliver direct POD perfusion/assessment runs in preclinical and partner labs with documented standards.
• Train external users; develop operator-qualification/training package and certify perfusionists and clinical staff.
• Support lead-in and pivotal site activation; ensure data capture and site-to-site standardization.; assist DSMB and events documentation.

Skills

Clinical background

Transplant experience

Ex-vivo perfusion

EVLP experience

Education

Perfusionist certification

Registered Nurse

Tools

GCP IDE exposure

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.