Product Development & Manufacturing Engineering Manager
Core
Leads a team to design, implement, and optimize automated manufacturing systems and processes for medical devices, improving efficiency and reducing costs.
Role type
Product Development & Manufacturing Engineering Manager
Builds
Automated manufacturing systems, metal products, and plastic assemblies for ophthalmic surgical devices
Domain
Medical devices / Ophthalmology / Manufacturing Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Metallurgical processing, CAD design (SolidWorks), GD&T, Lean manufacturing, Six Sigma, NPI, DFM, system commissioning, ISO 13485 compliance, FDA regulations
Preferred skills
Lean Six Sigma certification, CI/CD tools knowledge
Technologies
SolidWorks, 3D printing, CI/CD tools
Responsibilities
Design and optimize metal production processes integrating chemical engineering principles; Create 3D CAD models, drawings, and blueprints focusing on design for manufacturability; Conduct validation, testing, and commissioning of systems to ensure performance and safety; Develop verification/validation test protocols and analyze data; Create and maintain technical documentation including schematics and Manufacturing Work Instructions; Ensure compliance with ISO 13485 and FDA regulations managing design history files
Seniority
Manager, hands-on IC with team leadership