Project Engineer - Mechanical
Core
Project Engineer supporting the end-to-end development of Excelsius Cranial hardware and instrumentation, from concept through design, prototyping, testing, manufacturing, and FDA approval.
Role type
Mid-level mechanical engineering IC (product development)
Builds
Excelsius Cranial hardware and instrumentation
Domain
Medical devices / Orthopedics
Required skills
mechanical systems design, CAD software proficiency, design verification and validation, manufacturing test fixture development, regulatory compliance, root cause analysis, inspection procedures
Preferred skills
CREO Parametric CAD, Geometric Dimensioning & Tolerancing, medical device industry experience, Master's degree in Mechanical/Biomedical Engineering
Technologies
CREO Parametric, Pro/E, Solidworks, Microsoft Office
Responsibilities
Obtain market feedback to determine functional and design specifications; manage assigned projects ensuring timely completion and regulatory compliance; support creation of product requirements, specifications, and test documents; develop manufacturing test fixtures and documentation; partner with manufacturing and testing to resolve quality issues; perform design verification and validation activities; define and implement 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