Now hiring in Dallas, TX
Job Title: Process Engineer
Reports to: Director of Operations
Prepared Date: May 8, 2020
- 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.)
- 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.
- 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.