Manufacturing Engineer
Core
Develop, validate, and scale manufacturing processes for FDA-cleared soft tissue repair surgical devices.
Role type
Manufacturing Engineer
Builds
Surgical fixation and repair device systems
Domain
Medical devices / Orthopaedics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, equipment and tooling design, root cause analysis, process validation, change control, CAD (SolidWorks)
Preferred skills
Regulated environment experience, Lean/DMAIC methodologies
Technologies
SolidWorks
Responsibilities
Lead development and optimization of manufacturing processes, partner with R&D and Quality for design for manufacturability, develop and validate equipment/fixtures/tooling, support process transfer to high volume manufacturing, execute root cause analysis and corrective actions, support process validation and documentation compliance
Seniority
Entry level to 2 years experience