Senior Manufacturing Engineer

Responsibilities

• Design, specify, integrate, and support automated manufacturing and assembly equipment for high-volume consumables production, including robotics, vision systems, and automated inspection.
• Lead design-for-manufacturability and design-for-automation efforts for new and existing consumable products, partnering with R&D so parts are optimized for automated assembly, molding, and high-throughput production.
• Provide hands-on technical support to production for automated lines, troubleshooting equipment, minimizing downtime, and driving Overall Equipment Effectiveness (OEE) and yield improvements.
• Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), and Process Failure Mode Effects Analysis (PFMEA).
• Research, specify, and procure automation equipment and tooling; design and construct fixtures and modify existing production equipment to improve throughput, yield, and ergonomics.
• Develop and maintain automation control schemes, PLC/HMI configurations, and supporting documentation in coordination with internal teams and controls/automation vendors.
• Update and create manufacturing documentation (work instructions, BOMs) that conform to Quality System Regulations (QSRs) and ISO 13485 standards.
• Perform robust root cause analysis of production and equipment issues, implement appropriate containment, and drive corrective and preventive action.
• Examine and implement lean manufacturing techniques to reduce waste, improve flow, and increase capacity across consumables manufacturing cells.
• Support new product introduction (NPI) builds and the transfer of new consumable products and automated processes into production.

Qualifications

• Bachelor's Degree in Mechanical, Electrical, Manufacturing, or Automation Engineering
• 7+ years of manufacturing engineering experience, with a strong focus on manufacturing automation and high-volume consumable / plastic product manufacturing
• Hands-on experience designing, integrating, and supporting automated assembly equipment, robotics, and/or vision systems
• Experience with design for manufacturability and design for automation of injection-molded or single-use consumable products
• Proficiency with CAD software (SolidWorks preferred) for tooling, fixture, and equipment design
• Experience writing and executing IQ/OQ/PQ, DOE, and PFMEA
• Knowledge of QSR and ISO regulations (ISO 13485 a plus); medical device or life science manufacturing experience is helpful
• Familiarity with PLC/HMI automation, controls integration, and SCADA
• Good written and oral communication skills, including ability to communicate effectively at all levels of the organization
• Works well in a team, proactive, thrives in a fast moving environment