Director Medical Device Manufacturing Operations

Castle Biosciences, Inc.; Phoenix (AZ); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Excellent Annual Salary + 35% Bonus –

20 Accrued PTO Days Annually + 10 Paid

401K with 100% Company Match up to 6%

3 Health Care Plan Options + Company H

Company Stock Grant Upon Hire

Job summary

Castle Biosciences Inc. in Phoenix, AZ is hiring a Director of Medical Device Manufacturing Operations for a full-time, onsite role. You will lead the startup of a brand-new manufacturing facility, from equipment installation and process validation to building the team and establishing training programs.

The role focuses on day-to-day operations with emphasis on safety, quality, on-time delivery, and cost, while pursuing continuous improvement in a regulated FDA/ISO environment.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Operations Management, or related field.
• 10+ years of progressive manufacturing leadership in medical devices/biotech with 5+ years at director level.
• Experience leading startup operations, greenfield launches, or major facility expansions in FDA-regulated environments.
• Strong knowledge of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems.

Responsibilities

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

Skills

Manufacturing leadership

Startup operations

FDA/ISO compliance

Process validation

Team building

Cost and delivery focus

Education

BS in Engineering or Life Sciences

MBA / MS Engineering preferred

Job description

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood!

Learn more at www.CastleBiosciences.com

Castle Biosciences Inc. is growing, and we are looking to hire a full-time Director Medical Device Manufacturing Operations working from our Phoenix, AZ office location, with a start date on or before October 1, 2026.

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 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.

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

*Please see the full job description at the end of the job ad.

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.

READY TO JOIN OUR BIOTECH TEAM?

Castle Biosciences Awards and Research Developments!

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.

ABOUT CASTLE BIOSCIENCES INC.

At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.

Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.

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 [e-mail].

This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

** No third-party recruiters, please