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Process Engineer

2 months ago

Santa Ana, California, United States Autonomous Medical Devices Incorporated Full time
Job Overview

Autonomous Medical Devices Incorporated (AMDI) is seeking a highly skilled Process Engineer to join its dynamic team of engineers, scientists, and manufacturing experts. The successful candidate will lead multiple aspects of manufacturing equipment and process design and validation, supporting the sustaining manufacturing and operations of AMDI.

Key Responsibilities
  • Develop and implement manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions.
  • Design, execute, and document process validation protocols to ensure quality and regulatory compliance.
  • Provide on-demand pilot line support, managing manufacturing metrics, and ensuring adherence to quality and compliance procedures.
  • Identify and develop crucial equipment related to new product development and maintain appropriate uptime for current equipment.
  • Assist pilot line technicians and engineers on manufacturing problems, purchasing and designing equipment that meets safety and environmental requirements.
  • Communicate business-related issues or opportunities to next management level and ensure personnel and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
  • Lead or support troubleshooting activities and process improvements, performing root cause analysis of failures, and working on special projects as requested by management.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field is required.
  • Minimum of 2 years of industry process engineer experience is required.
  • Experience with commercial or pilot manufacturing lines, technical report writing, statistical analysis, and data evaluation is required.
  • Knowledge of good manufacturing practices and documentation is required.
  • Strong Project Management experience and skills are preferred.
  • The ability to influence others to achieve business objectives and excellent written and oral communication skills are required.
  • Knowledge of production processes, standard costs, and work standards is highly preferred.
  • Experience in a regulated industry is required, with medical device experience being a plus.
  • Ability to travel up to 10%, international and domestic, is required.
Desired Skills and Traits
  • Attention to Detail
  • Communication (written and verbal)
  • Computer Proficiency
  • Leadership
  • Microsoft Suite (Excel, Word, Outlook, PP)
  • Seasoned experience in multiple facets of manufacturing operations
  • Experience in Lean/Six Sigma
  • Hands-on leader who understands employee engagement, is a strong team builder, coach, and understands the importance of culture and being true to the core values of the organization
Work Environment
  • In-person position that requires working in a clean room environment that is humidity controlled.
  • Personal Protective Equipment (PPE) will be required to be worn at some stations.
Benefits
  • Company provided lunch to all employees when working at one of AMDI's on-site locations.
  • 401(k) match
  • Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance
  • Competitive vacation, sick days & paid holidays
  • Tuition reimbursement
  • Casual dress code
  • Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.
  • Monthly company-wide socials