Manufacturing Engineer,  Medical Device Industry

Location: Tustin, CA (On-Site)

Type: Full-time

Salary: $65,000-$85,000

Company: ClearPath Medical

About the Role

ClearPath Medical is seeking a Manufacturing Engineer to support the development and scale-up of custom medical devices. This role is ideal for an engineer who enjoys building structure around manufacturing processes, creating high-quality documentation, and helping new designs transition smoothly to production.

The ideal candidate has experience in regulated environments, a strong understanding of manufacturing operations, and a proven ability to create effective work instructions, PFMEAs, and process validations.

Key Responsibilities

• Develop and maintain manufacturing work instructions, assembly procedures, and inspection criteria for new and existing medical devices
• Lead and document Process Failure Modes and Effects Analyses (PFMEAs)
• Collaborate with design, quality, and production teams to implement design-for-manufacturability (DFM) principles
• Support new product introduction (NPI) through process development and validation activities (IQ/OQ/PQ)
• Create and update Bills of Materials (BOMs), routers, and tooling lists in the ERP system
• Drive process improvements to optimize efficiency, repeatability, and quality in manufacturing
• Assist with root cause investigations and corrective actions (CAPAs) related to process non-conformances
• Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements throughout all documentation and process changes
• Participate in and lead manufacturing readiness reviews, line setup, and operator training

• Bachelor's degree in Mechanical, Manufacturing, or Industrial Engineering
• 2+ years of experience in a medical device or other regulated manufacturing environment
• Strong experience creating work instructions and PFMEAs
• Working knowledge of ISO 13485, FDA QSR, and GMP principles
• Proficient in process documentation, risk analysis, and validation planning
• Familiarity with ERP and QMS systems
• Excellent communication skills and strong attention to detail

• Experience supporting cable assembly manufacturing
• Lean manufacturing or Six Sigma certification
• Proficiency in SolidWorks or other CAD software for tooling and fixture layouts
• Hands-on experience with assembly processes, jigs, and inspection techniques

• Competitive salary (based on experience)
• Full medical, dental, and vision coverage
• PTO and paid holidays
• Career advancement in a fast-growing company
• Work on cutting-edge technologies that improve lives