Sr. Manufacturing Engineer (Medical Devices)

Location: Onsite position based out of the office in Irvine, California, United States; requires up to 5% travel.

Salary: $110,000–$135,000 per year.

Company

hirify.global is a medical technology company developing the iLet bionic pancreas and type 1 diabetes management solutions.

What you will do

• Design, analyze, develop, and qualify manufacturing processes, materials, tooling, and fixtures.
• Apply Lean manufacturing principles to improve productivity and product quality.
• Perform root cause analysis and engineering problem solving.
• Coordinate multiple projects and priorities in a startup environment using Agile Scrum planning.
• Mentor junior engineers and personnel while leading tasks and goals.
• Maintain compliance with quality, safety, regulatory, and internal policies.

Requirements

• Bachelor’s degree in Mechanical Engineering or Manufacturing Engineering.
• 5–10 years of experience in a medical device environment.
• Experience in medical devices or consumer electronics and in FDA, GMP, or ISO environments.
• Knowledge of Quality System Regulations and GMP principles.
• Ability to use hand tools, operate electrical and mechanical equipment, and interpret results.
• Ability to read and interpret mechanical drawings and electrical schematics.
• Expert proficiency in SolidWorks and generating CAD drawings.
• Proficiency with Microsoft Office and online applications.
• Ability to work effectively in cross-functional teams, with minimal supervision, while communicating clearly and maintaining attention to detail.

Culture & Benefits

• Mission-driven, collaborative culture with significant ownership and impact.
• Professional office environment with personal protective equipment required for laboratory or field work.
• Physical duties include standing, walking, handling equipment, and occasionally lifting or moving up to 50 pounds.
• Comprehensive medical and dental coverage, with FSA and HSA options including an annual company HSA contribution.
• 401(k) program with employer match, vacation accrual, and paid holidays.
• Special projects may require extended work hours and some travel.