Senior Manufacturing Engineer

About the role

The Senior Manufacturing Engineer will lead the design, integration, and ongoing support of automated manufacturing equipment and processes for high-volume consumables products, including tubes, vials, and single-use sample preparation devices used with Adaptive Focused Acoustics (AFA) instruments. This role combines hands-on automation engineering with sustaining and continuous-improvement responsibilities to ensure reliable, scalable, and cost-effective production.

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.
• Perform other non-essential job-related duties as requested by supervisor.

Requirements

• 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 is a plus.
• Strong written and oral communication skills, with the ability to communicate effectively at all levels of the organization.
• Works well in a team, proactive, and thrives in a fast-moving environment.

Pay

The annual compensation range for this full-time position is $110,000 to $130,000. The final base pay offered will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.