Process Engineer: Medical Device Manufacturing & Validation

Phoenix VX; Albany (GA); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical premiums

401(k) match

Tuition reimbursement

Job summary

Phoenix VX is seeking a Process Engineer, Manufacturing Engineer, Validation Engineer, or Technical Services professional to own floor-level manufacturing improvements in a regulated medical-device environment.

You will lead validation activities, troubleshoot production issues, and drive technology transfers, lean initiatives, and cross-functional collaboration with Operations, Engineering, Quality, and Procurement.

Qualifications

• 3–5+ years of Medical Device and/or Pharmaceutical manufacturing experience.
• Background in Engineering, Science, Technology, or a closely related technical discipline.
• Demonstrated process and/or equipment validation experience.
• Strong technical writing capabilities.
• Knowledge of U.S. FDA and/or EU MDR medical device regulations.
• Experience working within a GMP-regulated manufacturing environment.
• Strong technical troubleshooting, analytical, and problem-solving capabilities.
• A Mechanical Engineering or Process Engineering background is particularly relevant.

Responsibilities

• Lead and support IQ/OQ/PQ process and equipment validation
• Troubleshoot complex manufacturing and production issues
• Author qualification documents, validation documentation, SOPs, and technical reports
• Analyze process data to identify risk, inefficiencies, yield improvements, and process capability opportunities
• Support new product launches and technology transfers
• Optimize existing commercial manufacturing processes
• Lead technical projects from investigation through implementation
• Partner with Operations, Engineering, Quality, Procurement, and Operational Excellence
• Support equipment/process qualification and continued process verification
• Contribute to Lean, Six Sigma, and continuous improvement initiatives

Job description

Phoenix VX is seeking a Process Engineer, Manufacturing Engineer, Validation Engineer, or Technical Services professional to own floor-level manufacturing improvements in a regulated medical-device environment.

You will lead validation activities, troubleshoot production issues, and drive technology transfers, lean initiatives, and cross-functional collaboration with Operations, Engineering, Quality, and Procurement.