Manufacturing Engineer III (Medical Device Manufacturing)

Location: Onsite in Irvine, California, United States; must be based within commuting distance of the office.

Salary: $121,200–$166,700 base salary annually, plus eligibility for a variable annual bonus.

Company

hirify.global develops, manufactures, and markets research and clinical diagnostic products, supporting scientific discovery and healthcare.

What you will do

• Lead the design, development, optimization, and sustaining support of manufacturing processes for existing and future products.
• Drive continuous improvement projects to increase capacity, reduce cost of goods, and improve manufacturing quality and reliability.
• Develop equipment and fixtures for environmental health and safety and improved capacity, including fabrication or supplier coordination, testing, qualification, and release of capital equipment.
• Manage quality management system updates, procedures, work instructions, change management, procurement, non-conforming product, and CAPA activities.
• Support manufacturing process compliance, product design sustaining, and new product transfers.

Requirements

• Bachelor’s or Master’s degree in an engineering or scientific field, preferably manufacturing, mechanical, industrial, or automation engineering.
• At least 7 years of industry experience, preferably in medical device manufacturing; packaging or manual assembly line experience is a plus.
• Strong documentation skills and understanding of the higher documentation standards and GDP required in regulated environments.
• Problem-solving skills for investigating product issues, determining root causes, and implementing effective solutions.
• Ability to conceptualize, design, fabricate or procure materials, or work with suppliers to fabricate, test, qualify, and release capital equipment and fixtures.
• Experience with an ERP system, preferably SAP.
• Substantiated experience implementing lean manufacturing concepts.

Culture & Benefits

• Full-time employee position with collaborative teams and opportunities to drive operational change.
• Medical plans, HSA funds, fertility benefits, group life and disability coverage, and paid parental leave.
• 401(k) with profit sharing, employee stock purchase program, paid time off, and pet insurance.
• Mental health support, wellness programs, employee resource groups, education benefits, learning and development opportunities, and student debt relief.
• Equal employment opportunity environment welcoming candidates of all backgrounds.