Manufacturing Specialist (Medical Devices)

Location: Northbridge, United States; onsite manufacturing environment

Salary: $36.06–$47.04 USD per hour

Company

hirify.global is an ophthalmology company developing and commercializing innovative therapeutics focused on preventing blindness and treating serious retinal diseases.

What you will do

• Perform complex manufacturing, assembly, packaging, labeling, inspection, and production support operations for combination products.
• Set up, operate, troubleshoot, and adjust manufacturing equipment and automated systems.
• Review batch records, device history records, logbooks, and other production documentation.
• Lead or support deviation, nonconformance, root cause analysis, CAPA, and other quality investigations.
• Support process validation, equipment qualification, engineering studies, and technology transfer activities.
• Train manufacturing personnel and collaborate with Quality, Engineering, Supply Chain, and Regulatory teams on operational improvements.

Requirements

• 5+ years of experience in a regulated manufacturing environment.
• Significant experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing.
• Advanced knowledge of cGMP regulations, Good Documentation Practices, and quality system requirements.
• Experience with manufacturing documentation, troubleshooting, investigations, process improvements, and personnel training.
• High School Diploma or GED required; an Associate's or Bachelor's degree in a relevant technical discipline is preferred.
• Ability to lift up to 25 lbs, wear PPE including cleanroom gowning, perform extended standing and repetitive motions, and complete an eye exam.

Nice to have

• Experience with electronic quality management systems.
• Prior experience as a lead operator, trainer, or subject matter expert.

Culture & Benefits

• Work in an ophthalmology-focused environment committed to patient safety, product integrity, and preventing blindness.
• Culture emphasizes transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Focus on safety, quality, accountability, regulatory compliance, and continuous improvement.
• Equal opportunity employer committed to diversity and inclusion.