Sr. Process Engineer

Responsibilities

• Provide technical and sustaining engineering support within manufacturing operations.
  
• Recommend and implement equipment and process modifications to improve production efficiency, quality standards, and manufacturing yields.
  
• Support process optimization initiatives through troubleshooting, root cause analysis, and implementation of corrective actions.
  
• Lead or support feasibility studies, material selection, process selection, equipment selection, tooling and fixture development, and equipment installation activities.
  
• Assess manufacturing process inputs and outputs to ensure alignment with operational and quality requirements.
  
• Manage and support process changes to improve manufacturing performance and operational efficiency.
  
• Support automated manufacturing systems including PLCs, HMIs, vision systems, sensors, motion controls, robots, and servos.
  
• Support and troubleshoot manufacturing technologies such as laser welding, ultrasonic joining, bonding, sealing, packaging, cleaning processes, and injection molding.
  
• Develop, execute, and support validation activities including Equipment IQ, Process OQ/PQ, Process Characterization, and Computer System Validation (CSV).
  
• Ensure manufacturing processes and procedures comply with company standards, FDA regulations, and quality system requirements.
  
• Collaborate with cross-functional teams including Manufacturing, Quality, Maintenance, Validation, and Operations.
  
• Support continuous improvement initiatives and technical project execution.
  

Requirements

Education

• Bachelor’s Degree required.
  

Experience

• Minimum of 5 years of relevant engineering experience required.
  
• Advanced degree with a minimum of 3 years of relevant experience may be considered.
  
• Experience in medical device manufacturing environment preferred.
  

Technical Skills

• Hands-on experience managing manufacturing processes, troubleshooting equipment, and implementing engineering projects.
  
• Strong knowledge of automated manufacturing systems and process controls.
  
• Experience with one or more of the following:
  • Pneumatics
    
  • Laser welding and ultrasonic joining
    
  • Sensors and controls
    
  • Robots and servo systems
    
  • Sealing and packaging technologies
    
  • Vision systems
    
  • Bonding processes
    
  • Cleaning processes
    
  • Injection molding
    
• Knowledge of PLCs, HMIs, motion controls, and automated process systems.
  
• Experience executing validation protocols and reports including:
  • Equipment IQ
    
  • Computer System Validation (CSV)
    
  • Process Characterization
    
  • Process OQ/PQ
    

Preferred Qualifications

• Experience supporting regulated manufacturing environments.
  
• Strong troubleshooting and analytical problem-solving skills.
  
• Experience leading process improvement and continuous improvement initiatives.
  
• Ability to work effectively within cross-functional teams.
  
• Strong communication and technical documentation skills.