Director Medical Device Manufacturing Operations

Castle Biosciences•Phoenix, AZ

3d•Onsite

About The Position

Castle Biosciences is growing and looking to hire a full-time Director Medical Device Manufacturing Operations to work from our Phoenix, AZ office location. This Director-level role will own everything from facility startup and process validation, to team building and day-to-day operations, all within an FDA-regulated environment. It's a high-visibility opportunity for someone who thrives on creating something from scratch and wants to make a real impact at a growing diagnostics company.

Requirements

Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field
10+ years of progressive manufacturing leadership experience in medical device, diagnostics, or biotechnology industries
At least 5 years in director-level or equivalent roles
Proven experience leading manufacturing startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments (21 CFR 820, ISO 13485, GMP)
Strong understanding of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.

Nice To Haves

Advanced degree (MBA, MS Engineering, or related) preferred

Responsibilities

Lead the 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 establishing the training and operational systems they need to succeed
Own day-to-day manufacturing performance including safety, quality, delivery, and cost
Drive continuous improvement and ensuring ongoing FDA/ISO compliance