Project Engineer - Mechanical
Core
Lead the end-to-end development of Excelsius Cranial hardware and instrumentation, from concept and design through prototyping, testing, manufacturing, and FDA approval.
Role type
Senior IC mechanical project engineer (medical devices)
Builds
Excelsius Cranial hardware and instrumentation
Domain
Medical device / Orthopedics / Neurosurgery
Deliverable
production ML models | product features
Required skills
mechanical systems design, CAD (CREO Parametric, Pro/E, Solidworks), design verification and validation, manufacturing test fixture development, regulatory compliance (FDA), root cause analysis, inspection procedure definition
Preferred skills
Geometric Dimensioning & Tolerancing (GD&T), medical device industry experience, Master's degree in Mechanical or Biomedical Engineering
Technologies
CREO Parametric, Pro/E, Solidworks, Microsoft Office
Responsibilities
Obtain market feedback from surgeons to define functional specifications; manage assigned projects ensuring timely completion and quality system compliance; support creation of product requirements and test documents; partner with manufacturing and testing to resolve quality issues; perform design verification and validation activities; define inspection procedures for incoming parts; assist with product introductions via sales training and customer visits; support sustaining activities including complaints and CAPAs.
Seniority
Mid-level, hands-on IC