Director Medical Device Manufacturing Operations

Why Castle Biosciences? Exceptional Benefits Package: Excellent Annual Salary + 35% Bonus Potential 20 Accrued PTO Days Annually + 10 Paid Holidays 401K with 100% Company Match up to 6% 3 Health Care Plan Options + Company HSA Contribution Company Stock Grant Upon Hire A DAY IN THE LIFE OF the Director Medical Device Manufacturing Operations We’re building a brand-new medical device manufacturing operation and need an experienced leader to build it from the ground up. 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. What you’ll do: 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 establish the training and operational systems they need to succeed; own day-to‑day manufacturing performance including safety, quality, delivery, and cost; while driving continuous improvement and ensuring ongoing FDA/ISO compliance.

REQUIREMENTS

Bachelor’s degree in Engineering, Life Sciences, Operations Management, or related field; advanced degree (MBA, MS Engineering, or related) preferred 10+ years of progressive manufacturing leadership experience in medical device, diagnostics, or biotechnology industries, with 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

SCHEDULE

This is a full‑time onsite role in Phoenix, Monday‑Friday, with hours that vary based on operational needs, especially during the startup phase.

WORK AUTHORIZATION

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.

EEO AND DISABILITY ACCOMMODATIONS

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e‑mail View email address on click.appcast.io. #J-18808-Ljbffr castlebiosciences