Manufacturing Manager

Description

We are changing the standard of care for millions of untreated sufferers of ENT conditions. We improve patient access to life-changing relief through safe, practical, and effective innovation that changes how and where patients are served. Aerin differentiates itself with our commitment to providing straightforward and clinically proven products so that ENTs and their patients can make treatment decisions together without limits.

At Aerin Medical our values show up as: always seeking the collective good, holding ourselves and each other accountable, showing respect with compassion, creation and innovation and being all in.

As the Manufacturing Manager you will be an essential part of our mission-driven team, dedicated to transforming the lives of those with untreated ENT conditions. Your role will involve contributing directly to our commitment to innovation and improved patient care.

The Manufacturing Manager owns how Aerin's products get built, from the production floor to the processes behind it. This is a player-coach role: you'll build product hands-on, solve problems in real time, and strengthen our manufacturing systems. As volume grows, you'll hire, develop, and lead the operator team that scales it.

Reporting to the Senior Director of Operations, the Manufacturing Manager is responsible for production, process improvement, materials operations, and the growth of the manufacturing team, ensuring products are manufactured in compliance with FDA QMSR (21 CFR Part 820), cGMP, and ISO 13485:2016. This role partners closely with R&D, Quality, Supply Chain, and external suppliers to support new product introduction, strengthen operational readiness, and improve efficiency, yield, and quality over time.

• Lead daily production activities and build product hands-on to meet the schedule
• Plan builds, allocate and kit components, and open and close work orders in ERP, ensuring accuracy against Material Transfer Form
• Review in-process LHRs for completeness and accuracy; resolve issues with Quality
• Establish production metrics and report on output, yield, and schedule performance

• Develop, document, and improve manufacturing processes, work instructions, and fixtures
• Lead or support process validations (IQ/OQ/PQ)
• Use data and root cause analysis to drive improvements in yield, throughput, and cost
• Own nonconformances, deviations, and CAPAs tied to production
• Partner with R&D on design transfer and new product introduction, and with suppliers on component and process issues

• Oversee inventory controls, cycle counts, and physical inventories; investigate and reconcile variances
• Partner with Purchasing on raw material replenishment
• Support order fulfillment, returns processing, and sterilization planning
• Ensure materials are properly labeled, identified, stored, and organized

• Build the manufacturing team: define operator roles, then recruit, hire, and onboard as production scales
• Train, coach, and develop operators; set clear expectations and give regular feedback
• Establish standards for productivity, safety, quality, and accuracy
• Maintain compliance with GDP, GMP, training requirements, and safety, fire, and hazmat guidelines

• BS in engineering or a related field preferred; equivalent experience considered
• 8+ years of medical device manufacturing experience, including 3+ years in a supervisory or management role
• Proven hands‑on production experience; comfortable building product yourself
• Experience hiring, training, and developing production staff
• Working knowledge of QMSR, ISO 13485, GMP, and GDP
• Experience with process…