Manager, Manufacturing Engineering (Medical Devices)

TL;DR

Manager, Manufacturing Engineering (Medical Devices): Leading the manufacturing engineering of infusion sets and managing new product introductions with an accent on process optimization, cost reduction, and supplier management. Focus on implementing Lean Manufacturing and Six Sigma techniques to enhance production efficiency and ensure strict compliance with FDA and GMP standards.

Location: Hybrid (Must be based in or able to commute to Irvine or San Diego, CA)

Salary: $142,000 - $177,000 per year

Company

hirify.global is a leader in diabetes technology, creating innovative insulin delivery systems like the Tandem Mobi and t:slim X2.

What you will do

• Lead and direct the manufacturing engineering for infusion sets, managing both sustaining and new development efforts.
• Oversee the transition of new products from prototype and pilot stages to full production.
• Supervise a team of engineers and technicians focusing on process automation and failure analysis.
• Define and implement product cost reduction activities and monitor key metrics such as yield and schedule adherence.
• Drive continuous process improvement using Kaizen, Lean Manufacturing, and Six Sigma.
• Develop validation protocols (IQ/OQ/PQ) and ensure adherence to Quality System Regulations.

Requirements

• Must be authorized to work in the U.S. without sponsorship.
• Solid knowledge and application of Quality System Regulations (QSRs/GMPs).
• Proficiency in Solidworks and MS Office (Word, Excel, PowerPoint).
• Experience driving quality and productivity improvements in a manufacturing environment.
• Ability to lead cooperative team efforts and effectively manage multiple priorities.

Nice to have

• B.S. degree in Science, Engineering, or a related field.
• 8+ years of experience in medical device manufacturing.
• 3+ years of experience managing manufacturing engineering staff.
• Experience working in an FDA/GMP/ISO regulated environment.
• Proven experience with Lean Manufacturing, Six Sigma, and Project Management.

Culture & Benefits

• Comprehensive health care benefits (medical, dental, vision) available from the first day.
• Financial perks including a 401k plan with company match and an Employee Stock Purchase plan.
• Generous time off with 11 paid holidays and a minimum of 20 days of PTO.
• Access to Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• Inclusive corporate culture focusing on a "people first" and "innovate every day" approach.