Cristcot logo
Cristcot

The work that we do today will impact the lives, of people we do not know, in a humanistic way.

Director, Device Manufacturing

Location

United States

Posted

18 days ago

Salary

0

Seniority

Lead

Bachelor Degree10 yrs expEnglishAssemblyPMP

Job Description

Director, Device Manufacturing

Cristcot

• 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.

Job 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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