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.

*Other duties may be assigned.*

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.

Work Methodology:

• Full time
• 100% on site job in Juncos- PR
• Administrative Shift
• Duration: 6 months (1st contract) with a high possibility of extension based on performance and budget.
• Professional services Contract
• Type of industry: Medical devices