Current Job Openings
PTS Advance is actively searching for a Process Engineer to join our industry-leading medical device client near Boca Raton, FL. The Process Engineer will be responsible for implementing new systems into the manufacturing process, while initiating cross-functional communication, and providing support to other departments such as development, design, labeling, and additional internal teams.
This rapidly expanding company invests in their team, allowing the Process Engineer to gain valuable hands-on experience in various areas within the facility, with the support for internal career progression.
Abbreviated List of Duties:
- Support assembly, labeling, packaging, and serialization of products.
- Support the design, qualification, and implementation.
- Perform troubleshooting and root cause, including CAPAs.
- Offer training of production equipment to personnel.
- Draft and update Engineering Protocols/Reports, Batch Records, Bill of Materials, Procedures, Forms, Design, Documentation, and additional relevant materials.
- Author CSV Documentation. Document activities to show accurate KPIs.
- Recognize areas for continuous improvement.
- Design and implement Validation Project, Final Reports, periodic reviews, as well as protocols and reports for Testing, IQ/OQ/PQ, and additional documentation/testing.
- Ensure compliance to safety and internal/external guidelines.
- Additional duties as described.
- Bachelor of Science in Biomedical Engineering or Biomechanical Engineering or similar education.
- 1-2 years of work within the medical device industry is preferred.
- Prior work with IQ/OQ/PQ.
- Prior Validation experience is a plus.
- Demonstrated knowledge of mechanical design principles, testing, and manufacturing processes.
- Understanding and demonstrated use of industry guidelines (FDA/ISO)
- Demonstrates Good Laboratory/Documentation/Manufacturing practices
We are actively interviewing! Please follow the listed steps or email your resume to Brittany.antonellis@Ptsadvance.com to apply.