Manufacturing Engineer

Gilero, a Sanner Group company, specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. We are seeking an experienced Manufacturing Engineer to join our Pittsboro, NC team.

About the role

As a Manufacturing Engineer, you will plan, develop, implement, and maintain manufacturing methods, processes, and operations for new and existing medical devices under medical device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). You will work independently and collaboratively to support and improve the manufacturing process through effective use of materials, equipment, and personnel.

Responsibilities

• Implement and improve manufacturing processes to produce cost-effective, high-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, product and tooling quotes, and 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.
• Identify and implement process improvement activities to increase yield, efficiency, or throughput.
• Support site management regarding Environmental, Safety, Manufacturing, and Facilities issues; lead continuous improvement in these areas as assigned.
• Characterize and optimize processes using statistical techniques, engineering knowledge, and experience.
• Troubleshoot processes or equipment and implement improvements to drive production line availability.
• Develop new and innovative ways to manufacture existing products.
• Write and execute protocols to assess changes to manufacturing process capability (IQ/OQ/PQ).
• Establish and optimize maintenance requirements for equipment based on historical mean time to failure.
• Perform Job Safety Analysis of new line installations.
• Train operators, quality control, and technicians on processes, equipment, and documentation.
• Provide engineering expertise in resolving specific technology issues.
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to manufacturing processes.
• Participate in process risk analysis activities (PFMEA) to support new or existing processes.
• Maintain Device Master Record (DMR) and ensure documents are complete, accurate, and current, including process routers, inspection plans, temporary deviations, and nonconformances.
• Monitor prices and equipment performance.
• Must be willing to work shifts, additional hours, and weekends/holidays as required by business needs or project deadlines.

Requirements

• BS in Engineering or equivalent technical degree.
• 1+ years of relevant work experience in manufacturing; 2+ years 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.
• Excellent communication skills (oral and written).
• Proficient computer skills, including Excel and Word.
• Must be permanently authorized to work in the United States without employer sponsorship.

Personal Attributes

• Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity.
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures while contributing to continuous improvements.

Benefits

• Competitive base salary plus incentive compensation.
• Annual performance bonus.
• Medical, dental, and vision insurance (multiple BCBS medical plan options).
• Company-paid life insurance, short- and long-term disability coverage.
• 401(k) with company match beginning the first month after start and immediate vesting in company match.
• Paid parental leave.
• Paid Time Off and company holidays.
• LinkedIn Learning for professional development.
• Career growth opportunities within Gilero and the global Sanner Group.