Onsite Medical Device Product Transfer Engineer

IntePros; Chandler (AZ); On-site; USD 80,000 - 110,000; Full time

Job summary

IntePros seeks a Product Transfer Engineer to support high-impact product transfer and manufacturing initiatives, collaborating with Product Transfer, Operations, Engineering, and Quality teams. The role emphasizes defining, validating, and documenting manufacturing processes aligned with quality requirements.

The engineer will develop and maintain SOPs, Device History Records, PFMEA, and Control Plans, train staff, and ensure GMP compliance through hands-on validation and continuous improvement

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 2+ years of manufacturing experience.
• Hands-on experience with equipment and/or process validations.
• Experience developing or writing procedures related to manufacturing or operating processes.
• Strong understanding of manufacturing processes and engineering principles.
• Demonstrated ability to troubleshoot and solve complex manufacturing or technical problems.
• Strong interpersonal and communication skills with the ability to work effectively with multidisciplinary teams.
• Proven ability to collaborate in a team-oriented environment while also working independently.

Responsibilities

• Provide engineering support for product transfers, ensuring activities are documented per procedures and quality requirements.
• Monitor project progress and ensure engineering activities are completed using sound engineering principles.
• Develop and maintain manufacturing documentation, including SOPs, Device/Manufacturing Records, DHR, PFMEA, and Process Control Plans.
• Develop and update procedures related to manufacturing and operating processes.
• Train operators, manufacturing personnel, and sustaining engineers on production processes and procedures.
• Write, execute, and document equipment, cleaning, and process validations.
• Ensure manufacturing processes and products meet quality, operational, and material specifications.
• Investigate manufacturing yield issues and identify opportunities to improve production processes.
• Implement process improvements to increase quality, efficiency, and manufacturing performance.
• Apply structured problem-solving techniques to address complex manufacturing and technical issues.
• Collaborate with cross-functional teams to identify solutions and drive projects through completion.
• Ensure compliance with GMP, quality, and safety requirements.

Skills

Hands-on manufacturing

Process validation

SOP writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering

Job description

IntePros seeks a Product Transfer Engineer to support high-impact product transfer and manufacturing initiatives, collaborating with Product Transfer, Operations, Engineering, and Quality teams. The role emphasizes defining, validating, and documenting manufacturing processes aligned with quality requirements.

The engineer will develop and maintain SOPs, Device History Records, PFMEA, and Control Plans, train staff, and ensure GMP compliance through hands-on validation and continuous improvement