Automation Engineer Iii

at Nissha Medical Technologies in Sandpoint, Idaho, United States

Automation Engineer III

Summary

Title:Automation Engineer III

ID: 2355

Department: Engineering

Location: Sandpoint, ID

Description

POSITION SUMMARY

The Automation Engineer III is an advanced engineering position also identified as Sr. Automation Engineer. This position usually works with minimum supervision, conferring with superiors on unusual matters. May be assisted by junior level Automation Engineers personnel as appointed by Automation Manager. Assignments are broad in nature, usually requiring originality and ingenuity. Has appreciable latitude for actions or decisions. Will be assigned to projects to act as the SME for automation under direction of Automation Manager. Will lead project status meetings, design reviews, and work with program management on scheduling, budget, and deliverables. The Automation Engineer III will be responsible for the outcome of the project.

ESSENTIAL DUTIES AND RESPONSIBILITIES(other duties may be assigned)

+ Project SME

+ Collaborate with customers (external and internal), team members, other departments, and other sites (as required) to develop conceptual designs.

+ Work with Automation Manager and/or Lead Automation Engineers on design decisions and paths.

+ Participate with SCRUM pre-planning on project tasks.

+ Participate in determining project deliverables and milestones.

+ Working with all departments to meeting specifications and schedule at cost.

+ Lead and participate in Design Review meetings

+ Lead and participate in Project Status updates with internal and external team members.

+ Responsible for the assigned automation project regarding on-schedule, cost, performance, and reliability. Responsible for meeting defined system requirements.

+ Responsible for adherence to ISO, FDA, OSHA, and other required compliance for the project.

+ Responsible for the project system design control verification and completion.

+ Automated Systems and Processes

+ Provide input and adhere to project development plans, system specifications, conceptual designs, and manufacturing concepts.

+ Design system and manufacturing processes to optimize manufacturing/operational performance.

+ Design of systems, tooling, and fixtures.

+ Design quality systems, such as vision systems, to inspect manufactured components to customer / product CTQs.

+ Create system design control documentation.

+ Create and execute validation protocols to ensure compliance with company policies,

+ Assist in system debugging for mechanical, electrical, and software along with useability.

+ Create system design specifications and requirements. Participate with quoting as required.

+ Create project development plans, system specifications, conceptual designs, and manufacturing concepts.

+ Present conceptual systems to internal and external customers.

+ ISO 13485, and FDA regulations in respect to customer requirements. Will submit statistical data analysis for review.

+ Lead and participate in design reviews and pFMEA reviews.

+ Attend and participate in customer update meetings and present progress as required.

+ Sustaining Automated Systems and Processes

+ Assist in Root Cause Analysis and CAPA Assessments.

+ Assist in Failure Investigations and Risk Management Reviews.

+ Facilitates system and/or tooling debugging/trails. Troubleshoot performance, design, and processes.

+ Assist with new user, operator, and/or technician training for systems.

+ Qualification and Validation: Develop plans to evaluate process and system repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.

+ Assist in Generating: Test Reports, Drawings, Procedures, Routers, Specifications, ECO's, SOP's, and other technician documentation.

+ Assist in the Machine Shop with machining as required. Training will be provided as required.

+ Develop and Provide training plans and training for operators, technicians, and other