Sr. Manufacturing Engineer

About the role

The Senior Manufacturing Engineer leads and coordinates the fabrication, installation, operation, maintenance, and repair of mechanical and electromechanical manufacturing systems. The position ensures quality and industry standards are consistently met or improved while driving efficiency, evaluates equipment performance and cost-effectiveness, and recommends design or process modifications to enhance reliability and reduce malfunctions.

Responsibilities

• 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
• 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 requirements

Requirements

• 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
• Familiarity with sterilization methods (EtO, gamma, e-beam) or cleanroom manufacturing

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance

Pay

Pay ranges from US$85,500 to US$142,500 USD annually. View the U.S. work location and transparency guide to find the pay range for your location.