Manufacturing Engineer - Medical Devices

Gilero is growing and looking for a Manufacturing Engineer that will be responsible for planning, developing, implementing and maintaining 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). In this position you will utilize previous experience and understanding to work both independently and in cooperation with project teams to support and improve the manufacturing process through the effective use of materials, equipment and personnel. The position will work out of our Pittsboro, NC manufacturing plant.

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, collaboration and excellence!

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.
• Identifies and implements 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 the existing product
• 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 the 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 weekend/ holidays as required by business needs or project deadlines

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• 3+ years relevant work experience in manufacturing
• 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

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.

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.