Neurosurgical Medical Device R&D Engineer

ClearPoint Neuro, Inc.

Carlsbad (CA)

On-site

USD 80,000 - 120,000

Full time

4 days ago

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Job summary

ClearPoint Neuro, Inc. is seeking a Medical Device R&D Engineer to support a range of neurosurgical devices from concept through production.

The role focuses on device development, design controls, verification/validation, and cross-functional collaboration to meet regulatory standards. The ideal candidate has a Biomedical Engineering background with at least 2 years of practical engineering experience, be proficient in CAD (SOLIDWORKS) and statistics (Minitab), and able to navigate design

Qualifications

Bachelor's degree in Biomedical Engineering or related field.
2+ years of hands-on engineering experience in technical groups.
Knowledge of medical device standards including quality systems, biocompatibility, sterilization, electrical safety, usability, and software development.

Responsibilities

Support device development across neurosurgery-focused products from concept to production.
Develop and manage design inputs/outputs and create design documents and change records.
Create and execute test protocols for verification and validation activities.
Coordinate with manufacturing to ensure design transfer feasibility and address production challenges.
Prepare documentation for regulatory submissions and liaise with regulatory affairs.