POSITION SUMMARY

The Automation Engineer is a mid-level engineering position that will assist other Automation Engineers or Automation Manager with design tasks, drawings, documentation, validation, troubleshooting and debugging, building and wiring systems, and implementation / training. Tasks will vary in difficulty and will require moderate evaluation, originality, and ingenuity. Work will be reviewed by a higher-level Automation Engineer or Automation Manager. Some customer interaction and travel between sites may be required.

The Automation Department is responsible for automated manufacturing systems throughout the company across all sites. Includes manual tooling and semi-automated systems as required.

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.
  • Create system design control documentation.
  • Create and execute validation protocols to ensure compliance with company policies,
  • 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 users.
• Assist Development, Manufacturing, and/or Quality departments as required.
• Abide by all safety and security rules set forth by the company and regulatory agencies.

• Requires a minimum of 2-years’ experience in an Automation Engineering
• Experience working in highly regulated environment.
• Experience with equipment and/or process qualifications and validations (IQ,OQ, PQ)
• Industrial Automation Experience Required
• Desired Disciplines:
  • Mechanical and Machine Shop Ability (required)
  • Software Development with PLC, SCADA, HMI, and motion (preferred)
  • Electrical with controls design (preferred)
• General office application computer skills required
• Strong working knowledge of 3D CAD (SolidWorks preferred)
• Understanding of Lean Manufacturing processes.
• Experience with quality standards such as ISO 13485, ISO 14971, FDA

Education
• BS in Mechanical or other engineering discipline. Manufacturing, Automation or Process Engineering experience may substitute for the education requirement on a year-for-year basis. 
Knowledge, Skills & Abilities
• Knowledge of mechanical, electrical, controls, and/or software in a manufacturing setting.
• Strong communication skills with the ability to explain complex information in an understandable language.
• Strong teamwork and interpersonal skills in working with employees, customers, and other departments.
• Flexible in responding to procedural changes and department/ employee needs and issues.
• Strong analytical skills with the ability to resolve problems by gathering necessary information to make an effective resolution.
• Ability to remain calm under pressure.
• Initiative and self-directed
• Patience in dealing with employee and interdepartmental issues.
• Strong reading and comprehension skills required.
• Detail oriented with attention to accuracy.
• Ability to multi-task and prioritize.
• Accountability & Dependability
• Ability to follow instructions with supervision and to provide timely updates to co-workers and management.
Physical Requirements This position requires the physical ability to: 
• Frequently remain in a stationary position for long periods of time.
• Occasionally move between buildings and offices
• Frequently operate a computer and other office equipment
• Frequently and successfully communicate with employees, managers, and members of the public, in person and on the phone, regarding sensitive matters, discern and convey emotion, and understand and exchange accurate information
• Occasionally lift and move up to 45 pounds
• Frequently recognize detail, inspect documents and product, observe behavior, and recognize potential violations or hazards
• Occasionally ascend/descend stairs to access work areas
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Special Work Conditions There is occasional exposure to airborne particles, toxic or caustic chemicals, outdoor weather conditions and risk of electrical shock, frequent exposure to moving mechanical parts and working in high precarious places. This position is exposed to loud noise level while in the production area. May be exposed to inclement weather when moving between buildings on site.
Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Nissha Medical Technologies will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call Human Resources at (208) 255-2571.