Manufacturing Manager

Aerin Medical Inc.; Mountain View (CA); Presencial; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical – PPO & HSA

Dental & Vision

401k

Wellbeing programs

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Production leadership

Process improvement

ERP systems

Data analysis

Communication

Educación

BS in engineering

Herramientas

Excel

MS Project

Descripción del empleo

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.

PURPOSE OF JOB

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.

POSITION SUMMARY

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.

MAJOR DUTIES AND RESPONSIBILITIES

Production Leadership

• 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

Process and Continuous Improvement

• 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

Materials and Inventory

• 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

Team Building

• 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

Requirements

EXPERIENCE 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

OTHER QUALIFICATIONS

• 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

BENEFITS AND PERKS

Our culture is rooted in our core values every day, in everything we do.

Our benefits focus on the 5 dimensions of wellbeing: physical, financial, emotional, career and community. Physical benefits include Medical – PPO & HSA with co-contribution, Dental, Vision, Accident Insurance, Critical Illness, Hospital Indemnity, and onsite Tonal & Peloton. Financial benefits include HSA/FSA, 401k, Lifestyle Spending Account, Long Term Disability, Life Insurance, a monthly stipend to cover phone and tech costs, employee discounts, and weekly office lunches. Emotional benefits include Employee Assistance Program, 5 free counseling sessions per issue per year, 80 hours sick leave, 13 holidays, and flexible vacation (exempt employees). Career and Learning & Development opportunities with Aerin led leadership trainings. Community initiatives which include Aerin “give back” week, family days as well as Aerin holiday giving.