Staff Industrial Engineer (Medtech)

TL;DR

Staff Industrial Engineer (Medtech): Driving manufacturing excellence through design influence in the development and optimization of manufacturing processes for medical devices with an accent on Design for Manufacturability (DFM) and regulatory compliance. Focus on implementing Six Sigma methodologies, overseeing process validations (IQ/OQ/PQ), and ensuring products are scalable and cost-effective.

Location: Must be based in Wayne, NJ (Hybrid: 1-2 days at home)

Salary: $125k - $140k

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Establish and standardize DFM and DFSS best practices and guidelines across engineering teams.
• Influence product architecture and material selection to ensure scalability, robustness, and cost-optimization.
• Develop and optimize manufacturing processes including molding, machining, laser processing, and automated assembly.
• Lead large-scale process validations (IQ/OQ/PQ), process characterization, and statistical justification.
• Serve as the technical escalation point for complex challenges, driving root-cause investigations and CAPAs to closure.
• Collaborate with suppliers on component manufacturability, tooling design, and qualification of new technologies.

Requirements

• Bachelor's or Master's degree in Industrial, Mechanical, Manufacturing Systems, or Biomedical Engineering.
• 8+ years of experience in DFM, process development, and product industrialization.
• Six Sigma Green Belt or Black Belt certification.
• Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis.
• Proficiency with CAD tools (SolidWorks, Creo), GD&T, and tolerancing methods.
• Knowledge of regulatory standards including ISO 13485 and FDA 21 CFR Part 820.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Tuition Reimbursement and Wellness initiative resources.
• Commuter Benefits and Life/Disability Insurance.