MedTech Manufacturing Engineer - Lean, GMP & Automation

MaximaTek; Fremont (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

MaximaTek is seeking a Manufacturing Engineer to design, optimize, and scale production processes in medical device contexts, bridging product design with large-scale manufacturing while upholding ISO 13485 and cGMP. You will lead lean workflows, IQ/OQ/PQ validation, CTQ/RCA analysis, and MES/ERP integration to ensure data integrity and regulatory compliance.

Ideal candidates have a degree in engineering and 0–5 years of manufacturing or robotics experience, with knowledge of CAD, Lean Six

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering (Required).
• 0–5 years of experience in manufacturing, process engineering, or academic research involving robotics and systems design.
• Technical Skills (Required): CAD software (SolidWorks, AutoCAD) and Lean Six Sigma / TQM.
• Familiarity with GAMP 5 frameworks for computerized system validation in manufacturing.
• Knowledge of 21 CFR Part 820 regarding Quality System Regulations for medical devices.

Responsibilities

• Process Optimization: Design and implement lean manufacturing workflows to improve throughput, reduce cycle times, and eliminate waste using DMAIC methodologies.
• Equipment Validation: Lead IQ/OQ/PQ activities for automated assembly lines and production machinery.
• Quality Engineering: Identify CTQ parameters and perform RCA on production deviations or NCRs.
• Systems Integration: Utilize MES and ERP platforms to monitor real-time production data and maintain data integrity.
• Technical Documentation: Author SOPs, Work Instructions, and validation protocols to ensure compliance with GxP requirements.
• Risk Management: Conduct PFMEA to proactively mitigate risks in the manufacturing environment.

Skills

CAD software

Lean Six Sigma

GAMP 5

21 CFR Part 820

PLC programming

Vision systems

Minitab

Python

Cleanroom

Education

Engineering degree (Mechanical/Biomedical/Industrial/Chemical)

Tools

MES

ERP

GxP software

Job description

MaximaTek is seeking a Manufacturing Engineer to design, optimize, and scale production processes in medical device contexts, bridging product design with large-scale manufacturing while upholding ISO 13485 and cGMP. You will lead lean workflows, IQ/OQ/PQ validation, CTQ/RCA analysis, and MES/ERP integration to ensure data integrity and regulatory compliance.

Ideal candidates have a degree in engineering and 0–5 years of manufacturing or robotics experience, with knowledge of CAD, Lean Six