Director Medical Device Manufacturing Operations

Director Medical Device Manufacturing Operations

Full‑time, Phoenix, AZ. Start date on or before Aug 1 2026.

• Excellent annual salary + 35% bonus potential
• 20 accrued PTO days annually + 10 paid holidays
• 401(k) with 100% company match up to 6%
• 3 health care plan options + company HSA contribution
• Company stock grant upon hire

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 is 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.

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; while driving continuous improvement and ensuring 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

• Full‑time onsite role in Phoenix, Monday‑Friday, with hours that vary based on operational needs, especially during the startup phase.

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.

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

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