Sr Manager, Manufacturing Engineering

Intuitive•Sunnyvale, CA

15h

About The Position

Primary Function of the 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 instruments product launches by designing manufacturing lines and equipment, improving manufacturing processes, creating and maintaining 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: Provide strategic and technical leadership to the Manufacturing Engineering organization. Ensure the professional development of individual team members. Establish group and individual objectives, priorities, and metrics. Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary. Lead the Manufacturing Engineering team to launch mid-volume MP instruments products. Ensure fulfillment of product development goals. 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. Specify, design, document, build and qualify the equipment necessary to perform each process step, while providing necessary manufacturing capacity. Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ). Analyze the data from current Manufacturing Operations to review trends, opportunities for improvement and implement changes on a continuous basis Ensure reliability and efficiency improvements of existing products Provide technical support for failure analysis and root cause investigation of product failures. Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation. Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.

Requirements

Minimum of ten years’ engineering experience manufacturing complex electro-mechanical products.
Ability to motivate, mentor, and inspire a high-capacity technical team.
Experience developing products from early-stage concept to volume manufacturing.
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.
Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software
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.
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.

Responsibilities

Lead a team of Product Manufacturing Engineers, in collaboration with other organizations, to support production of complex products
Provide strategic and technical leadership to the Manufacturing Engineering organization.
Ensure the professional development of individual team members.
Establish group and individual objectives, priorities, and metrics.
Manage and allocate team resources over multiple projects.
Provide and solicit resources to and from other teams as necessary.
Lead the Manufacturing Engineering team to launch mid-volume MP instruments products.
Ensure fulfillment of product development goals.
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.
Specify, design, document, build and qualify the equipment necessary to perform each process step, while providing necessary manufacturing capacity.
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
Analyze the data from current Manufacturing Operations to review trends, opportunities for improvement and implement changes on a continuous basis
Ensure reliability and efficiency improvements of existing products
Provide technical support for failure analysis and root cause investigation of product failures.
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.
Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures.