Principal R&D Engineer

About the Role

The Principal Catheter Engineer is a senior technical leader responsible for driving disposable catheter product development for LEADOPTIKs LIA™ platform, a disposable needle-based optical imaging catheter that provides real-time in-lesion tissue visualization during peripheral lung biopsy. LIA-1 is FDA cleared and in commercial use; the role spans ongoing enhancement of LIA1 informed by feedback from clinical use, and ground-up development of next-generation devices. This role combines deep hands-on prototyping expertise with strong command of design controls, verification validation, and quality system processes. The ideal candidate is equally comfortable at the bench building and testing prototypes and in the conference room defending design decisions during design reviews or regulatory audits, while also mentoring the next generation of engineers and technicians.

Responsibilities

• Lead technical efforts for LEADOPTIKs disposable product development, including commercial ramp of the cleared LIA-1 catheter (design changes, cost reduction, and supplier scaling), catheter development for next-generation devices, improving risk assessment methodology, and managing the Design History File (DHF).
• Design, build, and test catheter prototypes, including integration of optical fiber and imaging components; iterate rapidly through bench-top and in-vitro testing to converge on manufacturable designs.
• Author and execute design verification and validation protocols and reports; draft test methods and ensure traceability to design inputs/outputs.
• Own and maintain risk management documentation (dFMEA, pFMEA, URRA) in alignment with ISO 14971 and internal QMS procedures.
• Partner with Manufacturing, Quality, and Regulatory Affairs to transfer new designs and process changes from RD into production, including MPI development and validation (IQ/OQ/PQ as applicable).
• Drive root-cause investigations and CAPA activities for design- and process-related nonconformances.

Qualifications

• Bachelors or Masters degree in Biomedical, Mechanical, or Materials Engineering (or related field); 10 years of relevant medical device experience, with catheter or interventional device experience strongly preferred.
• Strong hands-on experience in prototyping disposable medical devices (catheter construction, bonding, reflow, assembly of multi-lumen/braided/coiled shafts, etc.).
• Expert-level knowledge of CAD software (e.g., SolidWorks). Capable of managing large CAD models.
• Experienced in Design Verification Validation (VV), and familiar with protocol and test method drafting.
• Familiar with QMS systems, including risk assessment, dFMEA, pFMEA, URRA (Use-Related Risk Analysis), and DHF (Design History File) content and structure.
• Demonstrated technical leadership in managing RD projects and training junior engineers/technicians on new Manufacturing Process Instructions (MPIs).
• Prior experience in E-beam or Gamma sterilization, ISO 10993 biocompatibility testing.

Preferred Skills

• Prior experience with the startup environment.
• Outstanding troubleshooting skills.
• Experience supporting a 510(k) or PMA submission.
• Hands-on experience with cleanroom assembly processes and environments.
• Experience with fiber optic, imaging, or sensing catheters (e.g., OCT, IVUS, or endoscopic imaging devices).