Senior Manufacturing Engineer
Core
Establish and develop manufacturing processes for new product development accessories and provide daily support for manufacturing operations and mechanical design improvements for existing robotic surgical instruments and accessories.
Role type
Senior Manufacturing Engineer (Medical Devices/Robotics)
Builds
Electro-mechanical components, assemblies, process documentation, tooling, manufacturing equipment, and test methods for robotic surgical instruments.
Domain
Medical device manufacturing / Robotics
Required skills
Process development, Process parameter development (DOE), Equipment selection, Test method development, Product and process validation & verification, Risk analysis (PFMEA), Equipment qualification (IQ/OQ/DQ/PQ), BOM specification, Workflow process design, Failure analysis, Medical device quality system compliance, Injection molding, Laser welding, Ultrasonic welding, Heat staking, CAD (Solidworks)
Preferred skills
New product introduction/development, Robotics knowledge, Automated equipment design, Complex mechanism manufacturing, ISO 13485/ISO 9001 environment experience, Catheter manufacturing processes, Leak test development, High volume automated assembly
Technologies
Solidworks, IQ/OQ/DQ/PQ, PFMEA, DOE
Responsibilities
Develop manufacturing assembly processes and test methods for new product development accessories; Design, document, procure, qualify, implement, and improve fixtures, tools and equipment; Analyze instrument/accessories manufacturing line from a risk perspective (PFMEA); Validate and qualify manufacturing equipment and processes; Create and maintain pilot manufacturing assembly lines; Provide production support through project launch; Identify and implement continuous improvement projects; Provide product and process DFx input; Maintain compliance with medical device quality system; Provide technical support analyzing and/or performing failure analysis.
Seniority
Senior, hands-on IC