Manufacturing Equipment Engineer 3

Job description

Primary Function of Position

Contribute your technical manufacturing, design, and project management skills to a dynamic development team creating high volume automation assembly lines for precision instruments and accessories. This position will focus on developing and executing manufacturing validation processes to achieve product safety, reliability, and KPI goals for the surgical accessories product line. Individuals in this role must demonstrate strong process development and capability analysis skills.provide daily support for manufacturing operations, design improvements for existing accessories and provide equipment engineering support for new product introductions.

Roles & Responsibilities

Function as plant contact for machine integrator in development, evaluation, and shipment of automation lines Validate, maintain, and improve high volume automation manufacturing assembly lines including: Document, procure, qualify, implement, and improve fixtures, hand tools and manufacturing equipment. Determine and incorporate critical feature inspection and test checkpoints into process. Develop manufacturing line equipment specifications to guide machine design.

Develop, maintain, and execute IQ/OQ/PQ and PPQ (qualification) documentation on high volume automation assembly lines. Identify and implement continuous improvement projects to improve first pass yield, cycle time reduction, product reliability, and cost reduction. Take responsibility for developing and maintaining compliance with the quality system. Provide design engineers with Design for Manufacturability and Design for Reliability input to ensure consistency/commonality among hardware and standard part selections across product/sub-assembly lines.

Create and maintain controlled documents such as: BOMs, workflow processes, manufacturing plan and detailed work instructions. Utilize design of experiments to determine best parameters for equipment operation.

Qualifications

Skills, Experience, Education, & Training

English Advanced level, read, written, spoken. 5+ years work experience as Equipment Engineer, Test Engineer, Automation Engineer, Mechatronic or similar. Medical device manufacturing experience a plus. New product introduction/development desirable. Controls/Robotics programming knowledge a strong plus. Experience with high volume automated assembly processes Experience with robotics and automated line controls (PLC, I/O Components, etc.) required Great attitude, eager, willing/able to take initiative, works well with others in team environment.

Experienced in ISO9001/13485, or medical device manufacturing environment a plus. CAD experience preferred (SolidWorks, AutoCAD). Able to travel periodically to USA-based suppliers.