Director, Device Manufacturing

Cristcot

2d

About The Position

The Director of Device Manufacturing will support Cristcot in its growth by leading the manufacturing operations of drug-device combination products. This role is responsible for managing contract manufacturers (CMOs) to ensure reliable, compliant, and cost-effective production of device components and finished combination products. Within Cristcot, the Director of Device Manufacturing will work closely across Operations, Manufacturing, Supply Chain, and Commercial. Outside Cristcot, the Director of Device Manufacturing will lead day-to-day operations for device and combination product manufacturing activities across clinical and commercial stages.

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 specifically in injection molding.
• Strong knowledge of device regulations: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP standards.
• Experience with drug delivery systems (e.g., applicators, rectal and vaginal delivery systems, injection molding).
• Proven experience supporting new product launches, preferably in a small or mid-sized company.
• Proven ability to lead cross-functional teams and manage contract manufacturing relationships.
• Experience with combination product design controls and human factors engineering.
• Familiarity with electronic documentation systems (e.g., MES, QMS platforms like Veeva or MasterControl).

Nice To Haves

• Master’s degree or MBA preferred.
• Six Sigma, Lean, or PMP certification preferred.
• Ability to travel 20-25%.

Responsibilities

• Manage and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director