Director Medical Device Manufacturing Operations
Listed on 2026-06-14
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Manufacturing / Production
Manufacturing Engineer, Medical Device Industry
Director Medical Device Manufacturing Operations
We are hiring a full‑time Director Medical Device Manufacturing Operations to work from our Phoenix, AZ office. The role includes a start date on or before August 1, 2026.
A Day in the LifeWe’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 owns everything from facility startup and process validation to team building and day‑to‑day operations, within an FDA‑regulated environment.
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 establish training and operational systems.
- Own day‑to‑day manufacturing performance, including safety, quality, delivery, and cost.
- Drive continuous improvement and ensure ongoing FDA/ISO compliance.
- 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.
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 AuthorizationAll candidates must be legally authorized to work in the United States. Castle Biosciences does not sponsor H‑1B visas, OPT, or employment‑related visas.
Equal OpportunityCastle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.
Accommodation RequestIf you have a disability and need a reasonable accommodation to search for a job opening or submit an application, please e‑mail Reasonable Accommodations
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- No third‑party recruiters, please.
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