Manufacturing Manager, Medical Devices & Growth

Aerin Medical Inc.; Mountain View (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical – PPO & HSA

Dental & Vision

401k

Wellbeing programs

Job summary

Aerin Medical is seeking a Manufacturing Manager to own how our products are built, from the production floor to the supporting processes. This is a hands-on player-coach role where you’ll build product, solve problems in real time, and eventually hire and lead a growing operator team.

Reporting to the Senior Director of Operations, you will oversee production, process improvement, materials operations, and ensure compliance with FDA QMSR (21 CFR Part 820), cGMP, and ISO 13485:2016.

Qualifications

• BS in engineering or related field; equivalent experience considered.
• 8+ years of medical device manufacturing experience, 3+ in leadership.
• Hands-on production experience with ERP, QMSR, ISO 13485, GMP, GDP.
• Experience hiring, training, and developing production staff.

Responsibilities

• Lead daily production activities and build product hands-on to meet the schedule.
• Plan builds, allocate components, and manage work orders in ERP.
• Review in-process LHRs, resolve issues with Quality, and drive yield improvements.
• Establish production metrics and report on output, yield, and schedule performance.
• Oversee inventory controls, supplier coordination, and sterilization planning.
• Build and develop the manufacturing team, train and coach operators, ensure safety and GDP/GMP compliance.

Skills

Leadership

Production leadership

Process improvement

ERP systems

Data analysis

Communication

Education

BS in engineering

Tools

Excel

MS Project

Job description

Aerin Medical is seeking a Manufacturing Manager to own how our products are built, from the production floor to the supporting processes. This is a hands-on player-coach role where you’ll build product, solve problems in real time, and eventually hire and lead a growing operator team.

Reporting to the Senior Director of Operations, you will oversee production, process improvement, materials operations, and ensure compliance with FDA QMSR (21 CFR Part 820), cGMP, and ISO 13485:2016.