Chief Operations Leader, Medical Devices & Manufacturing

Diality, Inc.; Irvine, Northern (CA, KY); Hybrid; USD 250,000 - 360,000; Full time

Job summary

Diality, Inc. in Irvine, CA is seeking a seasoned Vice President of Operations to scale manufacturing and supply chain for a medical device portfolio. You will lead cross-functional teams across R&D, Quality, Regulatory, and Commercial to deliver compliant, cost-efficient production capable of global scale.

The ideal candidate has 15+ years in regulated manufacturing, deep expertise in QMS, and a proven track record in startup or rapid-growth settings guiding complex devices from R&D to market.

Qualifications

• Bachelor’s degree in operations, engineering, or business with advanced degree preferred.
• 20+ years in operations leadership in medical devices or regulated manufacturing.
• Experience scaling manufacturing and global supply chains, and leading cross-functional teams.

Responsibilities

• Translate vision into scalable manufacturing and supply chain strategies.
• Oversee P&L for operations; drive cost optimization and budget control.
• Lead end-to-end program management and risk mitigation.
• Ensure QA and regulatory compliance with FDA/ISO13485 standards.
• Drive NPI and CapEx to support product pipeline and scale.

Skills

Interpersonal communication

Analytical thinking

Strategic leadership

Change management

Education

Bachelor’s in Operations/Engineering/Business

MBA preferred

Tools

ERP systems

Lean Six Sigma tools

Job description

Diality, Inc. in Irvine, CA is seeking a seasoned Vice President of Operations to scale manufacturing and supply chain for a medical device portfolio. You will lead cross-functional teams across R&D, Quality, Regulatory, and Commercial to deliver compliant, cost-efficient production capable of global scale.

The ideal candidate has 15+ years in regulated manufacturing, deep expertise in QMS, and a proven track record in startup or rapid-growth settings guiding complex devices from R&D to market.