Role OverviewWe'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.
What You Will 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;
Why It Might Be a Fit
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
- Proven experience leading manufacturing startup operations, greenfield site launches, or significant facility expansions in FDA-regulated environments
- Strong understanding of process validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems
Benefits
- 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
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