Equipment Engineer

Intuitive•Blacksburg, VA

12d

About The Position

Primary Function of the Position Contribute your technical manufacturing and equipment design skills to a dynamic development and manufacturing team that creates sensing & testing 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

Strong technical analytical and troubleshooting skills
Must possess strong communication skills to interface with many teams
Strong organizational skills and proven ability to work on several fast-paced projects simultaneously
Prior experience with technical writing
Mechanical CAD software experience (SolidWorks or equivalent)
Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
Minimum 3 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.
Prior responsibility for process, equipment, or product validation/verification

Nice To Haves

Programming skills is a plus
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
Prior experience with complex device manufacturing is a plus
Previous experience with ERP systems (preferred SAP) is a plus
Experience with line duplication and/or transfer is a plus

Responsibilities

Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions
Apply engineering concepts to the optimization of equipment and procedures to achieve better maintainability, reliability, capacity, and availability of equipment.
Independently and proactively determines and analyzes trends for equipment performance
Diagnose equipment breakdowns to define and implement improvement strategies.
Perform installation, repair, and upkeep services for a variety of equipment either in the fields of mechanics and electronics.
Deal with emergency and unscheduled problems/repairs of equipment
Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment
Responsible for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA
Responsible for the validation and qualification of manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ/DQ)
Responsible for handling multiple priorities and projects as a matter of routine
Able to operate independently to develop innovative solutions and processes
Orchestrates approach to determining root cause and problem solving on complex issues
Demonstrate leadership through knowledge transfer, mentoring, and training of others
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
Execute manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
Maintain compliance with medical device quality system including corrective action closure and Change Order implementation
Conduct SAP transactions relevant to equipment operations.
Provide technician training and oversee specified manufacturing stations to ensure quality.
Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress
Specify, fit, and integrate new equipment and ensure it is working properly, along with required documentation
Proactively seeks better and improved technologies for improving production processes
Provide resource planning and budget estimates for product and process improvements, tooling development, and testing
Improve existing documentation for equipment installation, repair, and upkeep.
Responsible for review of peer edits to documentation of fixtures, tools and equipment