Manufacturing Engineer

Intuitive•Sunnyvale, CA

About The Position

Primary Function of Position: Contribute your technical manufacturing and equipment design skills to a dynamic development and manufacturing team that creates sensing platforms for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments. The candidate must be able to coordinate their efforts with the development and manufacturing teams, and be able to report progress and milestones relative to the overall project. He or she must excel in a high-energy team environment and be capable of making sound decisions when faced with the time pressures and incomplete information typical of new product development and early stage manufacturing environments.

Requirements

Minimum BS/MS degree in Mechanical Engineering, Mechatronics, Electrical Engineering or Industrial Systems Engineering.
Minimum 3 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
Prior responsibility for process, equipment or product validation/verification.

Nice To Haves

Prior experience with complex device manufacturing is a plus
Experience in new product introduction/development desirable
CAD experience preferred
Previous experience with ERP systems (preferred SAP) is a plus
Programming skills is a plus
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus

Responsibilities

Create, maintain and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.
Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
Analyze 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/PQ).
Provide production support of sustaining and startup manufacturing lines.
Conduct testing of software releases before deploying on manufacturing line
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 Design for Manufacturability and Design for Assembly input to enhance manufacturability of new products.
Take 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.
Maintain all documentation associated with the manufacturing line.
Conduct SAP transactions relevant to manufacturing operations.
Provide technician training and oversee specified manufacturing stations to ensure quality.