Innovative Medical Device Manufacturing Engineer

Gilero, A Sanner Group Company; Pittsboro (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

Company paid life insurance

Short-term and long-term disability

401(k) with company match

Paid parental leave

Paid Time Off

LinkedIn Learning

Career growth opportunities

Job summary

Gilero, a Sanner Group company, seeks an experienced Manufacturing Engineer for our Pittsboro, NC location to plan, develop, implement and maintain manufacturing methods for medical devices under ISO 13485 and FDA 21 CFR Part 820 regulations.

You will support production operations, develop processes, write protocols, and lead continuous improvement to enhance yield, efficiency and quality.

Qualifications

• BS in Engineering or equivalent technical degree.
• 1+ years relevant manufacturing experience (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 or other 3D CAD software.
• Process validation experience.
• PLC controls knowledge and implementation.
• Strong communication skills (oral and written).
• Proficient in Excel and Word.

Responsibilities

• Implement and improve manufacturing processes to produce cost-effective quality medical devices.
• Support production operations including material disposition and daily manufacturing activities.
• Create, document and implement procedures and documents complying with GMPs.
• Conduct product testing, tooling reviews, and development of manufacturing processes and standards.
• Assess and implement process changes in response to customer requests or design changes.
• Identify and implement process improvements to increase yield and throughput.
• Lead Continuous Improvement in Environmental, Safety, Manufacturing, and Facilities areas.
• Characterize and optimize processes using statistical techniques.

Skills

Manufacturing leadership

Communication

Problem solving

Documentation

Education

BS in Engineering

Tools

SolidWorks

CAD modeling

Excel

Word

Job description

Gilero, a Sanner Group company, seeks an experienced Manufacturing Engineer for our Pittsboro, NC location to plan, develop, implement and maintain manufacturing methods for medical devices under ISO 13485 and FDA 21 CFR Part 820 regulations.

You will support production operations, develop processes, write protocols, and lead continuous improvement to enhance yield, efficiency and quality.