Manufacturing Engineer

MaximaTek; Fremont (CA); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Targeted Placement

Resume Rebuild

Interview Coaching

Job summary

MaximaTek seeks a Manufacturing Engineer to bridge product design and large-scale manufacturing in the medical device and pharmaceutical sectors. You will ensure life-saving products are built with precision, efficiency, and strict regulatory adherence (ISO 13485, cGMP).

You will design lean workflows, validate equipment, and drive quality through CTQ analysis, PFMEA, and robust documentation across MES/ERP-enabled environments. A strong CAD background and knowledge of GxP are essential.

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.
• Proficiency in CAD software for fixture design and floor layouts.

Responsibilities

• Design and implement lean manufacturing workflows to improve throughput and reduce cycle times.
• Lead IQ/OQ/PQ activities for automated assembly lines and production machinery.
• Identify CTQ parameters and perform RCA on deviations or NCRs.
• Utilize MES and ERP to monitor real-time production data and ensure data integrity.
• Author SOPs, Work Instructions, and validation protocols for GxP compliance.
• Conduct PFMEA to mitigate risks in manufacturing environments.

Skills

Lean Six Sigma

GxP

Regulatory compliance

Industrial engineering mindset

6 Sigma

Education

Bachelor’s or Master’s in Mechanical/Biomedical/Industrial/Chemical Engineering

Tools

SolidWorks

AutoCAD

Minitab

Python

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.