Senior Manufacturing Engineer (Laser Welding) (Medtech)

TL;DR

Senior Manufacturing Engineer (Laser Welding) (Medtech): Establishing engineering technologies for the production of the Aquabeam Robotic System with an accent on laser welding and process optimization. Focus on implementing DFM projects, designing specialized fixtures, and ensuring compliance with FDA QSR and ISO standards.

Location: Hybrid in San Jose, CA (Must be US-based)

Salary: $131,060 – $154,192 a year

Company

hirify.global is a medical technology company revolutionizing the treatment of benign prostatic hyperplasia through surgical robotics.

What you will do

• Lead engineering support for manufacturing by troubleshooting processes, fixtures, and equipment.
• Define the technology and equipment roadmap for medical device manufacturing.
• Implement Design for Manufacturability (DFM) projects to reduce costs and increase product reliability.
• Design and evaluate new fixtures, test methods, specifications, and layouts.
• Collaborate with R&D to develop weld schedules for transfer of new products into commercial manufacturing.
• Maintain critical process documentation, including PFMEA, Control Plans, and Manufacturing Instructions.

Requirements

• BS in Engineering (5+ years experience) or MS in Engineering (3+ years experience).
• Must be based in the United States.
• Extensive experience in root cause analysis and problem solving for technical and process issues.
• Working knowledge of FDA QSR, ISO 13485, and cGMP requirements for medical devices.
• Proficiency in CAD software, specifically SolidWorks.

Nice to have

• Subject matter expertise in laser cutting, welding, brazing, and joining.
• Experience leading technical projects in a cross-functional environment with CMOs and vendors.
• Experience applying Lean and Six Sigma tools.

Culture & Benefits

• Comprehensive health and wellness benefits package including full medical coverage.
• 401(k) plan with employer match.
• On-site gym and wellness programs.
• Flexible or paid time off, paid holidays, and paid parental leave.
• Commitment to a work/life blend and professional growth through dedicated management programs.