Director, Device Manufacturing

📋 Description

• Assist Cristcot in its expansion by overseeing the manufacturing operations of drug-device combination products.

• Manage contract manufacturers (CMOs) to guarantee dependable, compliant, and cost-effective production of device components and complete combination products.

• Supervise production timelines, equipment readiness, resource distribution, and performance metrics for the production line.

• Ensure adherence to GMP, FDA, ISO, and company quality standards in all device-related operations.

• Collaborate closely with Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams to facilitate product development, validations, launches, and the supply of commercial products.

• Assist in the technology transfer of device and combination product processes from development to manufacturing.

• Ensure on-time delivery of devices for clinical trials and commercial use.

• Foster relationships with external manufacturing partners, ensuring compliance with quality, delivery, and cost targets.

• Monitor supplier performance and conduct regular business and technical evaluations.

• Promote process enhancements, Lean Manufacturing initiatives, and troubleshooting for device assembly and packaging.

• Lead validation activities (equipment, process, packaging, and cleaning), ensuring conformity with regulatory requirements.

• Guarantee accurate and complete documentation, including batch records, deviation reports, CAPAs, and change controls.

• Support audits and inspections conducted by regulatory authorities and partners.

⛳️ Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Life Sciences, or a related technical field.

• Over 10 years of experience in medical device or combination product manufacturing, particularly in injection molding.

• Strong understanding of device regulations: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP standards.

• Demonstrated experience in supporting new product launches, preferably within a small or mid-sized company.

• Knowledge of 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 is preferred.

• Willingness to travel 20-25% of the time.

🏝️ Benefits

• Health insurance

• Retirement plans

• Professional development opportunities