Manufacturing Engineer - Medical Devices & Process Transfer

Aptyx; Charlotte (NC); On-site; USD 60,000 - 95,000; Full time

Job summary

Aptyx is seeking a Manufacturing Engineer I–II to support and advance the manufacture of interventional medical devices in a regulated environment. You will work closely with R&D, Operations, Quality, Supply Chain, and customers to transfer products from development into scalable production.

Level I focuses on foundational capabilities while Level II owns processes, leads projects, and resolves complex issues, driving transfer and continuous improvement across manufacturing functions.

Qualifications

• Experience in medical device manufacturing.
• Ability to work hands-on in a production environment.
• Understanding of IQ/OQ/PQ and process validation.
• Experience with product or process transfer from development to production.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Provide hands-on engineering support within the manufacturing environment to ensure quality, delivery, productivity, and cost.
• Develop, implement, and improve manufacturing processes for interventional medical devices, including catheters and implants.
• Support daily production by troubleshooting equipment, tooling, materials, processes, and product-related issues.
• Lead or participate in transfer planning, production launches, and ramp-up activities.
• Conduct process validation, CAPA, and continuous improvement activities.

Skills

Hands-on engineering

Problem solving

Lean Six Sigma

Cross-functional collaboration

Manufacturing processes

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related

Tools

SolidWorks

ERP systems

Job description

Aptyx is seeking a Manufacturing Engineer I–II to support and advance the manufacture of interventional medical devices in a regulated environment. You will work closely with R&D, Operations, Quality, Supply Chain, and customers to transfer products from development into scalable production.

Level I focuses on foundational capabilities while Level II owns processes, leads projects, and resolves complex issues, driving transfer and continuous improvement across manufacturing functions.