Director, Medical Device Manufacturing Operations - Startup

Castle Biosciences, Inc.; Phoenix (AZ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Salary + 35% bonus potential

20 days PTO + 10 holidays

401K with company match up to 6%

3 health care plans + company HSA

Stock grant on hire

Job summary

Castle Biosciences, Inc. is hiring a Director of Medical Device Manufacturing Operations for its Phoenix, AZ site. The role leads the startup of a new manufacturing facility, from equipment installation to first production runs, and builds the manufacturing team with strong training and SOP systems.

You will own daily performance across safety, quality, delivery and cost while driving continuous improvement in a FDA/ISO regulated environment. On-site, full-time role with growth opportunities.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field; MBA, MS preferred.
• 10+ years of progressive manufacturing leadership in medical device/diagnostics/biotech with at least 5 years at director level.
• Experience leading startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments (21 CFR 820, ISO 13485, GMP).
• Strong understanding of IQ/OQ/PQ process validation, equipment qualification, and manufacturing documentation systems.
• Full job description available at end of ad.

Responsibilities

• Lead startup and commercial launch of Castle's new manufacturing facility—from equipment installation and process validation through first production runs.
• Build and lead the manufacturing team, including hiring managers, supervisors, and technicians, and establish training and operational systems.
• Own day-to-day manufacturing performance including safety, quality, delivery and cost.
• Drive continuous improvement and ensure FDA/ISO compliance.

Education

Bachelor's degree in Engineering/Life Sciences/Operations Management

MBA or MS Engineering preferred

Manufacturing leadership (10+ years)

Experience in FDA-regulated startups/greenfield launches

IQ/OQ/PQ process validation knowledge

Equipment qualification and manufacturing docs systems

Tools

FDA/ISO compliance tools

Job description

Castle Biosciences, Inc. is hiring a Director of Medical Device Manufacturing Operations for its Phoenix, AZ site. The role leads the startup of a new manufacturing facility, from equipment installation to first production runs, and builds the manufacturing team with strong training and SOP systems.

You will own daily performance across safety, quality, delivery and cost while driving continuous improvement in a FDA/ISO regulated environment. On-site, full-time role with growth opportunities.