Manufacturing Engineer: Product Transfer & Process Validation

IntePros; Chandler (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

IntePros is seeking a Manufacturing Engineer to join a leading medical device client. You will support product transfer and manufacturing initiatives, collaborating with Product Transfer, Operations, Engineering, and Quality teams on the shop floor.

The ideal candidate has hands-on manufacturing experience, a strong grasp of process validation and documentation, and the ability to communicate across multidisciplinary teams to ensure processes are validated and ready for production.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 2+ years of experience working in a manufacturing environment.
• 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.
• Innovative and analytical mindset with an interest in identifying new and better ways to improve processes.
• Strong attention to detail and organizational skills.

Responsibilities

• Provide engineering support for product transfers, ensuring activities are completed and documented per procedures and quality requirements.
• Monitor project progress and ensure engineering activities are completed using sound engineering principles.
• Develop and maintain manufacturing documentation (SOPs, Device/Manufacturing Records, DHR, PFMEA, Process Control Plans).
• Develop and update procedures related to manufacturing and operating processes.
• Train operators 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 yield issues and identify opportunities to improve production processes.
• Implement process improvements to increase quality, efficiency, and manufacturing performance.
• Apply structured problem-solving techniques and collaborate with cross-functional teams to drive projects to completion.
• Ensure compliance with GMP, quality, and safety requirements.

Skills

Hands-on manufacturing

Problem solving

Cross-functional collaboration

Strong communication

Education

Bachelor's degree in Engineering

Job description

IntePros is seeking a Manufacturing Engineer to join a leading medical device client. You will support product transfer and manufacturing initiatives, collaborating with Product Transfer, Operations, Engineering, and Quality teams on the shop floor.

The ideal candidate has hands-on manufacturing experience, a strong grasp of process validation and documentation, and the ability to communicate across multidisciplinary teams to ensure processes are validated and ready for production.