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Posted 2mo ago

Manufacturing Manager

@ ProSomnus
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Pleasanton, California, United States
$170k-$180k/yrOnsiteFull Time
Responsibilities:Oversee production, Ensure compliance, Lead CAPA
Requirements Summary:Oversee end-to-end production operations for medical device manufacturing; ensure safety, quality, on-time delivery; lead CAPA and continuous improvement.
Technical Tools Mentioned:Lean, Six Sigma, Quality Management System (QMS), CAPA, PMP, Regulatory compliance
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Job Description

Position Summary

The Manufacturing Manager leads day-to-day production operations for ProSomnus’ manufacturing areas, ensuring we deliver safe, compliant, high-quality products on time while continuously improving operational performance. This leader is accountable for Safety, Quality, Delivery/Service, Unit Cost optimization, inventory management, and Engagement across the manufacturing organization, and will build capabilities through standard work, visual management, systems, process, problem solving, and development of supervisors and operators. This position reports directly to the CTO, and offers ample opportunities for career advancement. 

This role is hands-on and highly cross-functional—partnering with Quality, Engineering, Supply Chain, and Regulatory/Compliance to ensure readiness for growth, stable processes, continuous improvement, and effective change control. 


Core Responsibilities



  • Production Management: Oversee the end-to-end process of custom devices, from receiving patient-specific data/scans to final inspection and delivery.
  • Regulatory Compliance: Maintain strict adherence to FDA 21 CFR Part 820 and ISO 13485 standards.
  • Design Transfer: Coordinate with R&D and engineering to ensure that custom designs are safely and efficiently "transferred" into the manufacturing environment.
  • Quality Management (QMS): Manage the Corrective and Preventive Action (CAPA) process and lead root cause investigations for any non-conformances in custom builds.
  • Supply Chain & Vendor Oversight: Manage relationships with specialized suppliers and ensure that raw materials meet quality requirements.
  • Operational Excellence: Implement Lean or Six Sigma methodologies to reduce lead times for custom orders without sacrificing precision. 

 

Requirements & Skills

  • Education: Bachelor’s degree in engineering, Operations Management, or a related technical field.
  • Experience: 5–10 years in medical device manufacturing.
  • Certifications: Lean Six Sigma Green/Black Belt or Project Management Professional (PMP) are highly preferred.
  • Soft Skills: Strong leadership to manage cross-functional teams (Quality, Engineering, Logistics) and the ability to make rapid, data-driven decisions. 


Work Environment / Additional Requirements

  • Onsite presence required to lead daily operations; occasional off-hours support aligned with production needs. (Common for plant/operations leadership roles overseeing daily manufacturing performance.) 
  • Ability to meet typical manufacturing floor requirements (PPE, walking/standing, etc.). 


Why ProSomnus

  • Join a mission-driven medical device company improving OSA treatment outcomes through innovation and manufacturing excellence.
  • Make a direct impact on product quality, customer experience, and scalable operations.
  • Opportunity for career development
  • Competitive compensation and eligibility for stock options.