About the Role: Manufacturing Engineer
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.
Ready to Take the Next Step?
Email your updated resume to: vatsalya@maximatek.com
