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
