Medical Device Manufacturing Engineer: Growth & Impact

Gilero; Pittsboro (NC); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Medical/Dental/Vision insurance

401(k) with company match

Paid time off

Job summary

Gilero is seeking an experienced Manufacturing Engineer to join our Pittsboro, NC location. The role focuses on planning, developing, implementing and maintaining manufacturing methods for medical devices under ISO 13485 and FDA 21 CFR Part 820.

You will lead process improvements, document procedures, and support production operations to ensure GMP compliance and high yield. Strong CAD skills and regulatory knowledge are essential for success in this role.

Qualifications

• BS in Engineering or equivalent technical degree.
• 1+ years relevant work experience in manufacturing, 2+ preferred.
• Experience with medical device manufacturing preferred.
• Knowledge of medical device regulations (FDA/ISO).
• Proven ability to lead a manufacturing program.
• Experience with SolidWorks, and/or other 3D CAD modeling software.
• Process validation experience.
• PLC controls including changes and implementation.

Responsibilities

• Implement and improve manufacturing processes to produce cost-effective quality medical device products and systems.
• Provide support for production operations including material disposition, process updates and daily manufacturing activities.
• Create, document, and implement required procedures and documents while ensuring full compliance with GMP’s.
• Conduct product testing, prototype development, tooling review and recommendations, product and tooling quotes, development of manufacturing processes and testing standards
• Assess and implement process changes as required by customer request, in response to manufacturing quality issues, or design changes.

Skills

Manufacturing experience

Regulatory knowledge (FDA/ISO)

Process validation

Communication skills

Leadership / program management

Education

Bachelor of Science in Engineering

Tools

SolidWorks

3D CAD

PLC programming

Job description

Gilero is seeking an experienced Manufacturing Engineer to join our Pittsboro, NC location. The role focuses on planning, developing, implementing and maintaining manufacturing methods for medical devices under ISO 13485 and FDA 21 CFR Part 820.

You will lead process improvements, document procedures, and support production operations to ensure GMP compliance and high yield. Strong CAD skills and regulatory knowledge are essential for success in this role.