Manufacturing Manager

Position Summary

The Manufacturing Manager leads day-to-day production operations for ProSomnus’ manufacturing areas, ensuring safe, compliant, high-quality products on time while continuously improving operational performance.

Core Responsibilities

• Oversee the end-to-end process of custom devices, from receiving patient-specific data/scans to final inspection and delivery.

• Maintain strict adherence to FDA 21 CFR Part 820 and ISO 13485 standards.

• Career Transfer: Coordinate with R&D and engineering to ensure that custom designs are safely and efficiently "transferred" into the manufacturing environment.

• Manage the Corrective and Preventive Action (CAPA) process and lead root cause investigations for any non-conformances in custom builds.

• Manage relationships with specialized suppliers and ensure that raw materials meet quality requirements.

• 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.

Pay

Competitive compensation and eligibility for stock options.

Schedule

Onsite presence required to lead daily operations; occasional off-hours support aligned with production needs.