Director, Device Manufacturing
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Job Description
Director of Device Manufacturing at Cristcot overseeing the operations of drug-device combination products. Responsible for managing CMO relationships and ensuring compliance in production processes.
Responsibilities:
- Support Cristcot in its growth by leading the manufacturing operations of drug-device combination products.
- Manage contract manufacturers (CMOs) to ensure reliable, compliant, and cost-effective production of device components and finished combination products.
- Oversee production schedules, equipment readiness, resource allocation, and line performance metrics.
- Ensure compliance with GMP, FDA, ISO, and company quality standards in all device-related operations.
- Work closely with Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, launches and commercial product supply.
- Support technology transfer of device and combination product processes from development to manufacturing.
- Ensure timely delivery of devices for clinical trials and commercial products.
- Lead relationships with external manufacturing partners, ensuring adherence to quality, delivery, and cost objectives.
- Monitor supplier performance and conduct regular business and technical reviews.
- Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for device assembly and packaging.
- Lead validation efforts (equipment, process, packaging, and cleaning), ensuring compliance with regulatory standards.
- Ensure accurate and complete documentation including batch records, deviation reports, CAPAs, and change controls.
- Support audits and inspections by regulatory authorities and partners.
Requirements:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Life Sciences, or related technical field.
- 10+ years of experience in medical device or combination product manufacturing specifially in injection molding.
- Strong knowledge of device regulations: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP standards.
- Proven experience supporting new product launches, preferably in a small or mid-sized company.
- Experience with combination product design controls and human factors engineering.
- Familiarity with electronic documentation systems (e.g., MES, QMS platforms like Veeva or MasterControl).
- Six Sigma, Lean, or PMP certification preferred.
- Ability to travel 20-25%.
Benefits:
- Health insurance
- Retirement plans
- Professional development opportunities
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