Clinical Specialist

DEKA Research and Development; Manchester (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

DEKA Research and Development is seeking a Clinical Specialist to support POD perfusion device projects as they move toward clinical use. The person will embed with the DEKA team in Manchester, NH to master POD, then run perfusion in labs and train external users and trial personnel to standardize output across sites.

The role requires RN with transplant experience or a perfusionist/organ-preservation background, plus hands-on ex-vivo perfusion device experience.

Qualifications

• RN with deep transplant or organ-donation experience
• Hands-on with ex-vivo organ perfusion devices (EVLP, organ transport)
• Experience supporting FDA device studies, coordinating pre-clinical studies, and educating trial sites

Responsibilities

• Master and own the POD device, embedding with the DEKA team to achieve engineering-level competence
• Perform POD perfusion/assessment runs in preclinical and partner labs with standardized documentation
• Train and certify external perfusionists, technicians and clinical staff; proctor early cases
• Enable clinical-trial sites by supporting lead-in and site activation, data capture, and site standardization
• Maintain regulatory boundaries and avoid comparative or qualitative language in claims

Skills

RN transplant experience

Perfusionist experience

Field trainer / KOL credibility

Ex-vivo perfusion device knowledge

Education

Registered Nurse license

CCTC certification

Tools

EVLP / ex-vivo perfusion systems

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.