Manufacturing Engineer

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

We are seeking a motivated Manufacturing Engineer to design, optimize, and scale production processes within the medical device and pharmaceutical sectors. In this role, you will bridge the gap between product design and large-scale manufacturing, ensuring that life-saving products are built with precision, efficiency, and strict adherence to regulatory standards (such as ISO 13485 and cGMP).

Core 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 (Installation, Operational, and Performance Qualification) activities for automated assembly lines and production machinery.
• Quality Engineering: Identify "Critical-to-Quality" (CTQ) parameters and perform Root Cause Analysis (RCA) on production deviations or non-conformances (NCRs).
• Systems Integration: Utilize MES (Manufacturing Execution Systems) and ERP platforms to monitor real-time production data and maintain high levels of data integrity.
• Technical Documentation: Author Standard Operating Procedures (SOPs), Work Instructions, and validation protocols to ensure compliance with GxP requirements.
• Risk Management: Conduct PFMEA (Process Failure Mode and Effects Analysis) to proactively mitigate risks in the manufacturing environment.

Qualifications

• Education: Bachelor’s or Master’s degree in Mechanical, Biomedical, Industrial, or Chemical Engineering (Required).
• Experience: 0–5 years of experience in manufacturing, process engineering, or academic research involving robotics and systems design.
• Technical Skills (Required):
• Proficiency in CAD software (SolidWorks, AutoCAD) for fixture design and floor layouts.
• Strong understanding of Lean Six Sigma or Total Quality Management (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.
• Preferred Skills:
• Experience with PLC programming or automated inspection systems (Vision systems).
• Familiarity with Minitab or Python for statistical process control (SPC).
• Knowledge of cleanroom requirements and sterilization processes.

What We Offer

• Targeted Placement: Direct marketing to our network of hiring managers in the Life Sciences and MedTech industries.
• Resume Rebuild: Optimization of your profile to highlight engineering technicalities alongside GxP documentation skills.
• Interview Coaching: Guidance on technical case studies and regulatory compliance scenarios.