Sr. Manufacturing Engineer

What You Will Do

Design, develop, and validate manufacturing processes (IQ/OQ/PQ) for new and existing medical device product lines

Develop and maintain process FMEAs, control plans, and work instructions

Lead root cause analysis (RCA) and corrective/preventive action (CAPA) investigations for manufacturing nonconformances

Apply Lean and Six Sigma methodologies to reduce defects, cycle time, and manufacturing costs

Partner with R&D to ensure design-for-manufacturability (DFM) during new product development and Design Transfer activities

Collaboration with Regulatory Affairs and Quality on technical files

Define equipment specifications; lead procurement, installation, and commissioning of manufacturing equipment

Maintain calibration and preventive maintenance programs for production equipment

Ensure manufacturing documentation (DHR, DMR, batch records) is complete, accurate, and inspection-ready

Support internal, customer, and regulatory audits (FDA, Notified Body); prepare responses to audit findings

Maintain compliance with FDA, ISO 13485, and ISO 14971 requirement

What You Need

Bachelor’s degree in Mechanical engineering, Biomedical Engineering, Industrial Engineering, or related discipline

Minimum 5 years of engineering experience in a regulated medical device manufacturing environment

Hands-on experience with process validation (IQ/OQ/PQ) and Design Transfer

Working knowledge of ISO 13485 quality management systems

Proficiency with statistical analysis and process capability tools (e.g., Cpk, Gage R&R)

Experience authoring engineering documentation, including SOPs, work instructions, and validation protocols

Preferred

Master’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field)

Six Sigma Green Belt or Black Belt certification

Experience supporting Class II or Class III medical devices

Familiarity with ISO 14971 risk management and FMEA methodologies

Proficiency with CAD tools (e.g., SolidWorks) and ERP/MES systems

Experience supporting FDA inspections or Notified Body audits

Knowledge of sterilization methods (EtO, gamma, e-beam) or cleanroom manufacturing