Sr. Manager, Manufacturing

Prolaio • Chicago, IL

1d • $161,000

About The Position

The Senior Manager, Manufacturing is accountable for manufacturing operations, production planning, and operational execution in a regulated medical device environment. This role leads manufacturing readiness, workforce management, and cross-functional execution while partnering with Quality, Systems, Supply Chain, and Engineering to ensure compliant, efficient, and scalable operations. The role is responsible for maintaining a safe, controlled, and continuously improving manufacturing environment.

Requirements

• Bachelor’s degree in Engineering, Manufacturing, or related field
• 8 plus years of manufacturing operations experience in a regulated environment
• Prior people management experience
• Strong working knowledge of ERP systems, change control, and production planning
• Experience operating within FDA and ISO 13485–regulated environments, with a proven track record of audit readiness and compliance.

Responsibilities

• Own daily manufacturing operations including provisioning, kitting, returns management, and work order execution
• Lead production daily planning for WIP and MTS manufacturing and operational resource scheduling
• Manage and develop manufacturing personnel including training execution, growth path development, and performance management
• Maintain operational floor control and compliance, ensuring cleanliness, organization, and readiness to support manufacturing activities in a continuous state of control
• Own inventory control activities to ensure physical accuracy, traceability, and alignment with system records, maintaining inventory in a validated state of control
• Serve as manufacturing owner for change control implementation and operational execution
• Partner with Systems on ERP processes, item master data, BOMs, and manufacturing configuration
• Collaborate with Quality on SOPs, MWIs, and DMR related activities
• Support RCCP, S&OP, inventory planning, purchasing inputs, and depot planning with Supply Chain
• Ensure compliance with FDA, ISO 13485, and internal QMS requirements

Benefits

• Meaningful Compensation : Competitive salary, performance bonus, and equity so you can share in what we build.
• Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
• Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Time to Recharge: Generous paid time off, sick leave, and company holidays.
• Family-First Benefits : Paid parental leave, caregiver leave, and support for growing families.
• Security & Peace of Mind : Company-paid life insurance and short- and long-term disability coverage.
• Plan for the Future : 401(k) plan to help you build long-term financial security.
• Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager