Director, Device Manufacturing
Job Summary:
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.
Primary Relationships:
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.
Primary Job Responsibilities:
The Director of Device Manufacturing will manage and oversee production schedules, equipment readiness, resource allocation, and line performance metrics and will bring deep experience in medical device manufacturing, along with a strong understanding of pharma GMPs, FDA 21 CFR Part 820, and ISO 13485.
The Activities of the Director of Device Manufacturing will include, but are not limited to:
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.
Skills and Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Life Sciences, or related technical field.
Master’s degree or MBA preferred.
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.
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).
Six Sigma, Lean, or PMP certification preferred.
Ability to travel 20-25%.
Apply To This Job
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.
Primary Relationships:
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.
Primary Job Responsibilities:
The Director of Device Manufacturing will manage and oversee production schedules, equipment readiness, resource allocation, and line performance metrics and will bring deep experience in medical device manufacturing, along with a strong understanding of pharma GMPs, FDA 21 CFR Part 820, and ISO 13485.
The Activities of the Director of Device Manufacturing will include, but are not limited to:
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.
Skills and Qualifications:
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Life Sciences, or related technical field.
Master’s degree or MBA preferred.
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.
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).
Six Sigma, Lean, or PMP certification preferred.
Ability to travel 20-25%.
Apply To This Job