Manufacturing Mechanical Engineer

Intuitive•Sunnyvale, CA

About The Position

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

Requirements

Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
Strong technical analytical and troubleshooting skills.
Prior experience with managing product and process changes.
Strong organizational skills and proven ability to work on fast-paced projects simultaneously.
Prior experience with technical writing.
BS / MS degree in Engineering discipline or equivalent work experience.
3+ years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.

Nice To Haves

Prior responsibility for process, equipment or product validation/verification.
Prior experience designing automated equipment, complex mechanism manufacturing is a plus
CAD experience (preferred Solidworks).
Knowledge of a wide range of manufacturing processes, such as machining, injection molding, MIM, crimping, welding, testing of optical devices, and fiber routing is preferred
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus

Responsibilities

Create, maintain and improve “high-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
Independently and proactively determines and analyzes trends for equipment performance.
Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
Provide production line support for day-to-day engineering issues on core instrument lines i.e. resolve emergency and unscheduled problems/repairs of equipment.
Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of core instruments.
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.