Director, Technical Transfer & Process Improvement (Medtech)

TL;DR

Director, Technical Transfer & Process Improvement (Medtech): Overseeing the transition of diagnostic products from R&D to global manufacturing with an accent on process validation, technical transfer systems, and operational excellence. Focus on driving sustainable process improvements through Lean Six Sigma, managing global technical teams, and ensuring ISO 13485 compliance.

Location: Onsite in Camarillo, CA, US

Salary: $150,000 - $190,000 annually + bonus

Company

hirify.global provides rapid microbiology diagnostic tests and solutions for mission-critical processes, focusing primarily on global food safety.

What you will do

• Serve as the technical SME for establishing and piloting manufacturing processes for new product introductions.
• Lead root-cause investigations into complex product or process failures and implement systemic CAPAs.
• Develop and execute IQ/OQ/PQ validation protocols for new equipment, processes, and materials.
• Establish and oversee best practices for technical transfer from R&D to global manufacturing.
• Direct a global team of manufacturing scientists, technical transfer specialists, and process improvement engineers.
• Apply Lean and Six Sigma methodologies to optimize processes and reduce waste across global sites.

Requirements

• Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, or a related field.
• Minimum 10 years of experience in laboratory or manufacturing environments, including cGMP and aseptic techniques.
• Minimum 3 years of supervisory experience managing direct reports.
• Expert knowledge of technical transfer, process piloting, and process validation.
• Six Sigma Green or Black Belt Certification required.
• Strong understanding of ISO 9001/13485 systems and CAPA processes.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance with HSA employer contribution.
• 401(k) plan with Safe Harbor and Profit-Sharing employer contributions.
• 15 days of PTO and 10 paid company holidays.
• Tuition reimbursement program and charitable contribution matching.
• Company-paid life, short-term, and long-term disability insurance.