Process Engineer

Now hiring in Dallas, TX

Job Title: Process Engineer

Reports to: Director of Operations

Prepared Date: May 8, 2020

 

Job Description:

  • Uses risk management approach to develop workflow, work station, and equipment improvement recommendations.
  • Identifies equipment and processes needing validation; develops and supports execution of corresponding validation protocols and reports (including IQ, OQ, and PQ).
  • Writes training material and provides training on new processes or equipment modifications.
  • Ensures that processes and equipment used in production and in support of the Quality Management System are developed, validated and maintained in compliance with regulatory and corporate requirements.
  • Provides support for design controls and risk management relative to product development.
  • Works with Quality to propose solutions for process improvements related to corrective actions (CAPA).
  • Works with Product Development to identify new processes and improvements to current processes to support the production of new devices.
  • Supports the facilitation of other quality processes (nonconformance, corrective actions, change control, audits, etc.)

 

Training Requirements:

  • Employee shall be made aware of and trained on all standard procedures relating to his/her responsibilities.
  • Receives instruction on specific assignment objectives, points of emphasis, reference and information sources. Unusual problems are solved jointly with supervisor.

 

Interrelationships:

  • Works within Operations to develop, implement, and establish control over production processes.
  • Works with Quality to develop and maintain documentation that demonstrates control of processes.
  • Works with Product Development to develop production processes for new product.

 

Education/ Skill Requirements

  • Bachelors degree in engineering or science.
  • Minimum 2 years’ manufacturing engineering experience, including experience with validation of processes and equipment.
  • Experience conducting risk management studies (including FMEAs)
  • Strong communication and technical writing skills.
  • Ability to work effectively in team situations as well as independently.
  • Preferred knowledge of 21CFR 820 or ISO 13485 standards.
  • Preferred experience with 3D printing, CNC, NX and other CAM software.