MaximaTek · 22 hours ago
Manufacturing Engineer
Wyoming, United States
Full-time
Onsite
New Grad, Entry, Mid Level
0+ years expMaximaTek is seeking a motivated Manufacturing Engineer to design, optimize, and scale production processes within the medical device and pharmaceutical sectors. The role involves bridging the gap between product design and large-scale manufacturing while ensuring compliance with regulatory standards.
Management Consulting
Hiring Manager
Sai Teja Kothapally
Responsibilities
Design and implement lean manufacturing workflows to improve throughput, reduce cycle times, and eliminate waste using DMAIC methodologies
Lead IQ/OQ/PQ (Installation, Operational, and Performance Qualification) activities for automated assembly lines and production machinery
Identify "Critical-to-Quality" (CTQ) parameters and perform Root Cause Analysis (RCA) on production deviations or non-conformances (NCRs)
Utilize MES (Manufacturing Execution Systems) and ERP platforms to monitor real-time production data and maintain high levels of data integrity
Author Standard Operating Procedures (SOPs), Work Instructions, and validation protocols to ensure compliance with GxP requirements
Conduct PFMEA (Process Failure Mode and Effects Analysis) to proactively mitigate risks in the manufacturing environment
Qualification
Required
Bachelor's or Master's degree in Mechanical, Biomedical, Industrial, or Chemical Engineering
0–5 years of experience in manufacturing, process engineering, or academic research involving robotics and systems design
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
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
Benefits
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.
Company
MaximaTek
Maxima Technologies is a privately owned, leading professional IT services firm Based in Cheyenne, WY.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase