Manufacturing Manager

Aerin Medical•Mountain View, CA

3d•$100,000 - $130,000

About The Position

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.

Requirements

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 validation, NCR/CAPA, and work instructions
ERP experience required
Equally comfortable on the build bench and leading a team meeting
Communicates clearly with operators, engineers, and leadership alike
Proficient in Excel, Word, PowerPoint, and MS Project

Responsibilities

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