Senior Process Engineer - Medical Devices

Gilero is growing and looking for an experienced Senior Process Engineer to support development and manufacturing of exciting assembly automation projects for medical and pharmaceutical delivery devices. 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!

The position is responsible for developing new manufacturing systems for emerging technologies to support the production of medical devices under device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). In this role, you will be responsible for designing and implementing manufacturing processes and supporting projects on a scale that can range from developmental pilots to full commercial production.

Develop and deliver new manufacturing process capabilities as needed including process selection, characterization and qualification utilizing designed experiment methodology (DOE).

• Serve as an electromechanical/automation SME within the department, helping to build this skillset within the team.
• Specify and manage external build contractors, install, troubleshoot, and validate automated equipment and processes for complex device assembly and testing.
• Develop and deliver new manufacturing process capabilities as needed including process selection, characterization and qualification utilizing designed experiment methodology (DOE)
• Evaluate new device designs for manufacturability (DFM/DFA)
• Establish process flow and line layouts to achieve efficient, flexible, and scalable manufacturing cells
• Utilizes Lean Thinking, Six Sigma and 5S concepts when creating new or improving existing processes.
• Specify new process equipment for manual and fully-automated production lines
• Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
• Generate CAD models for test or assembly fixtures
• Establish maintenance requirements for new equipment
• Evaluate the impact of new processes introductions on critical environments
• Assess and implement process changes as required by customer request, in response to manufacturing quality issues, or design changes.
• Perform process risk analysis through PFMEA activities 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 non-conformances.
• Participate in manufacturing investigations/CAPA resolutions to identify improvements to the manufacturing processes.
• Support quality audits of manufacturing processes
• Drive Continuous Improvement activities within the manufacturing area to meet and exceed operational objectives and goals
• Develop processes and rates for customer quotations in response to inquiries while working with Tooling, Engineering, Purchasing, and Customer Service to obtain needed information
• Facilitate design transfer of existing products to and from other manufacturing sites.
• Lead project activities through the management of budgets, resources, timelines, and deliverables
• Provide engineering expertise in resolving specific technology issues during development and provide support to the production team during ramp and sustaining activities
• Communicate effectively with customers and vendors in a technical capacity

• BS in Engineering or equivalent technical degree.
• Minimum 5 years relevant experience in manufacturing medical devices.
• Knowledge of medical device regulations (FDA/ISO)
• Experience with Solid Works, Pro/Engineer and/or other 3D CAD modeling software, preferred.
• Experience with drug filling and handling for combination products, strong plus.
• Ability to program PLC, Arduino, or other motion controllers, strong plus.
• Experience incorporating vision systems into manufacturing equipment for use in in-process inspection and/or motion control, a plus.
• Excellent communication skills (oral and written)
• Proficient (or better) computer skills, including Excel and Word

• Meets Gilero Core Values:
  Collaboration, Integrity, Innovation, Excellence
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customer
• Commitment to established policies and procedures, while contributing to continuous improvements

• 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…