Technical Lead, NPI Manufacturing Engineer (Medical Robotics)

Location: San Jose, California; onsite role

Salary: $124,000–$155,000 USD annually

Company

hirify.global is developing next-generation medical robotics for the early diagnosis and treatment of patients across multiple indications.

What you will do

• Lead and guide the Manufacturing Engineering team through new product introduction and sustaining activities.
• Manage manufacturing engineering processes, improvements, deliverables, documentation, workflows, layouts, inventory planning, and equipment maintenance plans.
• Implement lean manufacturing, continuous improvement, and data analytics initiatives to improve productivity and reduce process costs.
• Lead PFMEA, production testing, equipment and process validation, and qualification activities using IQ/OQ/PQ approaches.
• Resolve design, manufacturability, quality, supply chain, production, and field-return issues while providing DFM feedback to R&D.
• Support assembly, testing, troubleshooting, fixtures, production technicians, and compliance with FDA requirements and ISO 13485.

Requirements

• Bachelor’s degree in industrial or mechanical engineering, or an equivalent combination of education and experience in medical devices or highly regulated manufacturing.
• Minimum 5 years of manufacturing engineering experience with complex electromechanical devices and medical devices.
• Experience with QSR/FDA and ISO 13485:2016 requirements or a highly regulated manufacturing environment.
• Ability to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, and basic schematics.
• Good written and verbal communication skills with employees at all levels, suppliers, and internal customers.
• Ability and motivation to grow professionally.

Culture & Benefits

• Full-time employment with health, dental, vision, HSA, and FSA options.
• 401(k), stock purchase, equity and bonus programs, life and disability insurance.
• 12+ paid holidays, flexible time off, sick time, and paid parental leave.
• Tuition reimbursement, online training, book reimbursement, and other learning opportunities.
• In-office snacks, beverages, lunch stipend, and company-organized team events.
• No agencies; resumes must not be submitted without a signed agreement from Talent Acquisition.