Medical Device Manufacturing Engineer - Process Innovator

Gilero; Chicago, Northern (IL, KY); Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Paid parental leave

Paid time off

LinkedIn Learning

Career growth

Job summary

Gilero, a Sanner Group company, seeks an experienced Manufacturing Engineer to join our Pittsboro, NC site. You will plan, develop, implement and maintain manufacturing methods and processes for medical devices under GMP and regulatory standards.

The role requires collaboration with cross-functional teams, process validation, PFMEA, and training operators to ensure product quality and manufacturing efficiency. Some travel may be required as needed.

Qualifications

• BS in Engineering or equivalent technical degree.
• 1+ years relevant manufacturing experience; 2+ preferred.
• Experience with medical device manufacturing preferred.
• Knowledge of FDA/ISO regulations.
• Proven ability to lead a manufacturing program.
• Process validation experience.
• Experience with SolidWorks or other 3D CAD software.

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 GMPs.
• Conduct product testing, prototype development, tooling review and recommendations, development of manufacturing processes and testing standards.
• Assess and implement process changes as required by customer requests or design changes.
• Identify and implement process improvement activities to increase yield, efficiency or throughput.
• Train operators, quality control, and technicians on processes, equipment, and documentation.

Skills

Communication skills

GMP knowledge

Medical device manufacturing

Statistical analysis

3D CAD (SolidWorks)

Education

BS in Engineering

Tools

SolidWorks

PLC programming

Excel

MS Word

Job description

Gilero, a Sanner Group company, seeks an experienced Manufacturing Engineer to join our Pittsboro, NC site. You will plan, develop, implement and maintain manufacturing methods and processes for medical devices under GMP and regulatory standards.

The role requires collaboration with cross-functional teams, process validation, PFMEA, and training operators to ensure product quality and manufacturing efficiency. Some travel may be required as needed.