Manufacturing Engineer will support the introduction of new products and manufacturing processes within a regulated medical device environment. The role focuses on equipment validation, process development, and ensuring manufacturing processes comply with regulatory and quality requirements. The engineer will work closely with cross\-functional teams to support equipment qualification, process validation activities, and production line implementation.
Responsibilities:
- Design and develop manufacturing processes, procedures, and production layouts for assemblies, equipment installation, and material handling.
- Support new product introduction (NPI) activities including process development and validation.
- Execute equipment qualification activities (IQ/OQ/PQ) and support process validation lifecycle.
- Develop and execute validation protocols and reports for manufacturing equipment and processes.
- Support process characterization, operational qualification, and performance qualification activities.
- Develop and update Standard Operating Procedures (SOPs) and manufacturing documentation.
- Support change control processes in compliance with medical device regulations.
- Assist in statistical analysis and design of experiments (DOE) using tools such as Minitab.
- Provide line support during special builds and production activities.
- Investigate manufacturing issues, implement corrective actions, and ensure product quality.
- Collaborate with engineering teams to optimize manufacturing processes and equipment utilization.
- Ensure manufacturing processes comply with regulatory and quality system requirements.
*Other duties may be assigned*
Requirements
Minimum 3 to10 years of relevant engineering experience in manufacturing, validation, or process engineering within a regulated industry.
Bachelorâs Degree in Engineering completed.
Top 3 Candidate Experience Requirements:
- Equipment Qualification (IQ) experience
- OQ / PQ or Process Validation experience
- Process Validation Lifecycle knowledge (Process Characterization â OQ â PQ)
- DOE (preferred using Minitab)
Technical Skills (Must Have):
- Experience performing Equipment Qualification (IQ).
- Experience with Operational Qualification (OQ) and Performance Qualification (PQ).
- Knowledge of the Process Validation Lifecycle (process characterization â OQ â PQ).
- Experience supporting process validation within a regulated environment.
Preferred Technical Skills:
- Experience with Design of Experiments (DOE) using Minitab.
- Experience with Injection Molding Processes.
- Experience in Process Development and Documentation.
- Experience with Equipment Validation.
- Experience supporting Special Builds and Manufacturing Line Support.
Additional Skills:
- Computer System Validation (CSV)
- SOP Development
- Change Control in Medical Devices
- Experience with MES systems
- Documentation management within regulated industries
*Willing to work 100% On\-site in Villalba,PR*.
