Manufacturing Engineer

IntePros is currently seeking a Manufacturing Engineer to join one of our leading medical device manufacturing clients. This role will support high-impact product transfer and manufacturing initiatives, working closely with Product Transfer, Operations, Engineering, Quality, and other cross-functional teams.

The Product Transfer Engineer will provide engineering support throughout the product transfer process, ensuring manufacturing processes are well-defined, validated, documented, and ready for production. The ideal candidate will have hands-on manufacturing experience, a strong understanding of engineering principles and process validation, and the ability to communicate and collaborate effectively across multidisciplinary teams.

The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.

Product Transfer Engineer Responsibilities:

• Provide engineering support for product transfers , ensuring activities are completed and appropriately documented according to established procedures and quality requirements.
• Monitor project progress and ensure engineering activities are completed using sound engineering principles.
• Develop and maintain manufacturing documentation, including:
• Standard Operating Procedures (SOPs)
• Device/Manufacturing Records
• Device History Records (DHR)
• Process Failure Mode and Effects Analyses (PFMEA)
• 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 established quality, operational, and material specifications.
• Investigate manufacturing yield issues and identify opportunities to improve production processes.
• Implement process improvements designed to increase quality, efficiency, and overall 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 applicable GMP, quality, and safety requirements
• Perform other related duties as assigned.

Product Transfer Engineer 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.

Product Transfer Engineer Preferred Qualifications:

• Experience working within an FDA-regulated or other highly regulated manufacturing environment
• Experience executing equipment and process validations
• Experience in the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industry
• Familiarity with manufacturing quality systems and documentation requirements.
• Experience supporting new product introductions, product transfers, or manufacturing transfers

Work Environment:

This is a fully onsite position

Travel is not expected to be a regular requirement; however, occasional travel to another company manufacturing facility may be required during the course of the assignment.

What we are looking for:

The ideal candidate is a hands-on engineer who enjoys being close to the manufacturing floor and solving real-world production challenges. You should be comfortable working with operators, engineers, quality professionals, and other stakeholders while taking ownership of technical projects and ensuring processes are properly validated and documented. xhyhwjd

Strong communication and collaboration skills are essential, as this position will interact with a broad range of internal teams and stakeholders.