Sr. Hardware, Manufacturing Engineer (onsite)

ResMed

Chatsworth, CA, United States
Base: $117,000 to $175,000; bonus/equity: not spec...
On-site
Electro-mechanical medical devices
Tooling, fixtures, and production equipment
Dfm/dfa reviews
ResMed is seeking a Senior Hardware Manufacturing Engineer to lead the design and industrialization of tooling and production equipment for medical devices. The role requires extensive experience in manufacturing engineering, particularly within regulated environments, and offers a comprehensive benefits package

Job Summary

  • Lead hands-on manufacturing process development for electro-mechanical medical devices from prototype through production.
  • Manage external machine shops, automation vendors, and contract manufacturers through RFQ, DFM review, and build iterations.
  • Partner with Quality to support complaints, NCRs, audits, and inspections (FDA, ISO 13485).

Matching Summary

Match Score: 85

ResMed is seeking a Senior Hardware Manufacturing Engineer to lead the design and industrialization of tooling and production equipment for medical devices. The role requires extensive experience in manufacturing engineering, particularly within regulated environments, and offers a comprehensive benefits package.

Salary

Base: $117,000 to $175,000; Bonus/Equity: Not specified; Benefits: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.

Skills & Requirements

Must-have

  • electro-mechanical medical devices
  • tooling, fixtures, and production equipment
  • DFM/DFA reviews
  • process validation (IQ/OQ/PQ)
  • GMP principles
  • troubleshoot complex manufacturing issues

Nice-to-have

  • tolerance stack-up analysis
  • fixture design for bonding
  • automation, vision systems
  • Lean manufacturing or Six Sigma

Key Requirements

  • Bachelor's degree in mechanical, Electrical, Manufacturing, or Biomedical Engineering
  • 7+ years of hands-on manufacturing engineering experience
  • Proficiency in 3D CAD (SolidWorks, Creo, or equivalent)
  • Direct experience with process validation (IQ/OQ/PQ)
  • Working knowledge of GMP principles

Work Rights

Not specified

Tailored Resume

Cover Letter