Manufacturing Engineering Technician II (Medtech)

TL;DR

Manufacturing Engineering Technician II (Medtech): Performing manufacturing operations and developing support processes for insulin pump production with an accent on compliance with QSR and cGMP practices. Focus on designing production support processes, executing validation protocols, and implementing Lean Manufacturing techniques.

Location: Fully onsite in San Diego, California

Salary: $25.19 - $31.47 per hour

Company

hirify.global creates innovative products and services, including the Tandem Mobi and t:slim X2 insulin pumps, to improve the lives of people with diabetes.

What you will do

• Maintain, operate, and develop processes to support overall manufacturing operations.
• Assess manufacturing processes for strict compliance with QSRs and cGMP practices.
• Design, implement, and maintain production support processes and documentation change order packages.
• Develop equipment operating procedures (EOPs) and preventative maintenance (PM) plans.
• Execute process validation and qualification protocols and document findings.
• Provide training to production personnel on procedures and process changes.

Requirements

• Must be authorized to work in the U.S. (no sponsorship provided)
• 4+ years of experience in Instrumentation, Biomedical Industries, or Consumer Electronics.
• Experience working within FDA, GMP, or ISO regulated environments.
• Strong knowledge of QSRs and cGMP documentation skills.
• Associate degree in a technical discipline or equivalent applicable job experience.
• Working knowledge of small scale electromechanical device assembly operations.

Nice to have

• Experience with Lean Manufacturing and 6 sigma techniques.

Culture & Benefits

• Human-centered approach to design and development with a "people first" mentality.
• Collaborative environment focused on innovation in diabetes technology.
• Temporary assignment through a staffing agency partner.
• Possibility of conversion to regular full-time status based on business need and performance.

Hiring process

• Pre-employment screening process including a drug test and background check.