About The Position

The Senior Manager, Advanced Manufacturing Maintenance is responsible for leading and developing a high-performing team responsible for optimizing maintenance operations across immunoassay manufacturing in a regulated diagnostics environment. This role ensures maximum equipment uptime, regulatory compliance, and safe, efficient operations by overseeing a multidisciplinary team supporting biochemical and electromechanical systems. Combining strong leadership with technical and operational expertise, the role drives maintenance strategies that enhance equipment reliability and enable continuous improvement within an FDA-regulated setting. This position is part of the Global Engineering team and is an on-site role based in Chaska, Minnesota.

Requirements

  • Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Biomedical) or related field along with 14+ years of experience OR master degree in engineering or related field along with 12+ years of experience
  • Experience in maintenance, engineering, or operations preferably within regulated manufacturing (medical device, diagnostics, pharma, or biotech).
  • 4+ years of leadership experience managing technical teams.
  • Strong technical expertise across electrical, mechanical, pneumatic, hydraulic, and automation systems.
  • Working knowledge of PLC/HMI platforms (Rockwell preferred), robotics, vision systems, and industrial networks.
  • Proven ability to lead in fast-paced, high-volume environments, with flexibility to support off-shift or on-call operations.

Nice To Haves

  • Experience in IVD, medical device, pharmaceutical, or life sciences manufacturing, including diagnostics/reagent production.
  • Lean Six Sigma certification (Green Belt or higher) with experience in highly automated manufacturing environments.
  • Familiarity with digital maintenance tools, IoT, and Industry 4.0 technologies.

Responsibilities

  • Lead and develop a cross-functional team of equipment and automation technicians, fostering a culture of safety, quality, accountability, and continuous improvement.
  • Design and execute preventive, predictive, and corrective maintenance strategies for manufacturing systems.
  • Troubleshoot and repair highly automated equipment across electrical, mechanical, pneumatic, hydraulic, robotics, vision, motion control, and PLC/HMI systems.
  • Support installation, commissioning, qualification, and lifecycle management of new and upgraded automation equipment.
  • Implement condition-based and data-driven maintenance practices to improve uptime, OEE, and equipment reliability.
  • Partner with Manufacturing, Engineering, Quality, and Supply Chain; serve as the primary maintenance contact for audits, deviations, and change control.
  • Ensure compliance with FDA, GMP, ISO, and safety standards; track KPIs (uptime, MTTR, MTBF) and drive continuous improvement using Lean/Six Sigma.

Benefits

  • paid time off
  • medical/dental/vision insurance
  • 401(k)
  • bonus/incentive pay
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