Sr. Process Engineer

MG STAFFING GROUP•Juncos, PR

98d

About The Position

The Sr. Process Engineer will provide technical and sustaining engineering support within manufacturing operations. This role involves recommending and implementing equipment and process modifications to improve production efficiency, quality standards, and manufacturing yields. The engineer will support process optimization through troubleshooting, root cause analysis, and corrective action implementation. Responsibilities also include leading or supporting feasibility studies, material and process selection, equipment and tooling development, and installation activities. The position requires assessing manufacturing process inputs and outputs for alignment with operational and quality requirements, managing process changes, and supporting automated manufacturing systems and various manufacturing technologies. A key aspect of this role is developing, executing, and supporting validation activities and ensuring compliance with company standards, FDA regulations, and quality system requirements. Collaboration with cross-functional teams and support for continuous improvement initiatives are also essential.

Requirements

Bachelor’s Degree required.
Minimum of 5 years of relevant engineering experience required.
Advanced degree with a minimum of 3 years of relevant experience may be considered.
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.

Nice To Haves

Experience in medical device manufacturing environment preferred.
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.

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.