Manager Instruments Manufacturing Engineering

Intuitive•Sunnyvale, CA

About The Position

Primary Function of Position:Contribute your technical manufacturing, leadership, and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. This key technical management role will guide and mentor a talented engineering team responsible for supporting NPI instrument manufacturing by creating manufacturing processes, authoring all associated manufacturing documentation, dispositioning discrepant material, and maintaining compliance with our quality system.Essential Job Duties Lead a team of Product Manufacturing Engineers, in collaboration with other organizations, to support production of complex products with responsibilities including but not limited to:Establish group and individual objectives, priorities, and metricsEnsure fulfillment of product development goals for NPI projectsEnsure the professional development of individual team membersEnsure production of products meets expected outputEnsure quality requirements are fulfilled and maintainedMaintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru AgileProvide technical support for failure analysis and root cause investigation of product failuresPlan, budget and staff projects, tracking performance throughoutManage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessaryWork with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development proceduresImprove product quality, yields, and reduce costImprove the manufacturing process as neededComplete cost analysis and lead cost reduction effortsMentor and train new employeesCreate, maintain and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.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 (DQ/IQ/OQ//PQ).Provide production line support for day-to-day engineering issues on core instrument and NPI linesIdentify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.Other related duties

Requirements

Successful experience leading projects
Minimum of five years' engineering experience manufacturing complex electro-mechanical products.
Ability to motivate, mentor, and inspire a high capacity technical team.
Prior responsibility for validation of processes, equipment and products.
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK.
Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously.
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers.
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Able to travel periodically to suppliers or Intuitive Mexicali plant
Minimum B.S. degree in engineering discipline, M.S. preferred.

Nice To Haves

Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment.
Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments.
Prior experience with Class III medical devices
Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software
Experience developing products from early stage concept to volume manufacturing.

Responsibilities

Establish group and individual objectives, priorities, and metrics
Ensure fulfillment of product development goals for NPI projects
Ensure the professional development of individual team members
Ensure production of products meets expected output
Ensure quality requirements are fulfilled and maintained
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
Provide technical support for failure analysis and root cause investigation of product failures
Plan, budget and staff projects, tracking performance throughout
Manage and allocate team resources over multiple projects.
Provide and solicit resources to and from other teams as necessary
Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures
Improve product quality, yields, and reduce cost
Improve the manufacturing process as needed
Complete cost analysis and lead cost reduction efforts
Mentor and train new employees
Create, maintain and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
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 (DQ/IQ/OQ//PQ).
Provide production line support for day-to-day engineering issues on core instrument and NPI lines
Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
Other related duties