Manufacturing Engineer

The Manufacturing Engineer will be responsible for managing manufacturing documentation, processes, equipment, and production-readiness activities for both existing and new medical devices. This role involves developing and qualifying manual manufacturing processes, maintaining build documentation, ensuring equipment and facility compliance, and supporting production planning. The position requires a hands‑on approach to process improvement, cross‑functional project organization, and support for products from development through routine manufacturing.

• Maintain and update manufacturing documentation, including BOMs, routers, work instructions, process specifications, and manufacturing records for new and existing products.
• Develop and qualify manual manufacturing and assembly processes, including creating qualification plans, protocols, and supporting records.
• Identify, implement, and document tools, fixtures, gages, and equipment to ensure safe and efficient production.
• Coordinate production planning and readiness, ensuring all materials, components, and documentation are available and identifying any shortages or constraints.
• Oversee calibration, preventive maintenance, and cleanroom monitoring activities, ensuring all are scheduled, completed, and documented appropriately.
• Lead troubleshooting efforts, root cause analysis, and process improvements to reduce defects, improve yield, and support CAPA and change‑control activities.
• Collaborate with cross‑functional teams during product development to address manufacturability, lead manufacturing transfer, and execute qualification projects.
• Define, organize, and execute manufacturing projects, ensuring clear scope, timelines, deliverables, and effective communication with stakeholders.

• 5+ years of hands‑on Manufacturing Engineering experience in an ISO 13485 medical device manufacturing environment.
• Proven ownership of manufacturing processes and documentation, including BOMs, routers, work instructions, and change control.
• Experience developing, documenting, and qualifying manual assembly or manufacturing processes, including validation protocols and reports.
• Skilled in selecting and implementing tools, fixtures, gages, and equipment, with experience in equipment qualification, calibration, and preventive maintenance.
• Strong background in production support and process improvement, including troubleshooting, root cause analysis, and corrective action implementation.
• Experience coordinating production readiness, material availability, and working with suppliers and cross‑functional teams.
• Familiarity with cleanroom manufacturing, including monitoring, facility controls, and maintenance documentation.
• Demonstrated ability to define and manage manufacturing or operations projects, coordinate resources, and drive actions to completion.
• Excellent technical writing, organizational, and cross‑functional communication skills.
• Bachelor's degree in Manufacturing, Mechanical, Biomedical, Industrial, or related Engineering discipline required; equivalent direct medical device manufacturing experience may be considered.
• Certified Manufacturing Engineer, Six Sigma, ASQ CQE, PMP, or related technical/project‑management certification preferred.
• Experience with catheter‑based devices, sterile single‑use disposables, electromechanical medical devices, or similar products is highly desirable.
• Knowledge of EO sterilization, ISO 11135, ISO 14644, Lean manufacturing, Six Sigma, SPC, DOE, and supplier qualification is a plus.
• Experience with ERP/MRP planning tools, CAD, electronic QMS, calibration/maintenance systems, Minitab, and Excel preferred.
• Hands‑on, practical, and able to work directly with production personnel, equipment, suppliers, and facilities.
• Ability to turn ambiguous needs into clear processes, documentation, and sustainable routines.
• Strong leadership through influence, high ownership, urgency, attention to detail, and sound judgment.