Manufacturing Engineer
Description:
About the job Manufacturing Engineer
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 Required Qualifications
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 Preferred Qualifications
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 What We Offer
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