Summary:
We are seeking a Process Engineer to join our team and support a client in the medical device industry. The Process Engineer will provide technical support for manufacturing processes, with a strong focus on process validation, troubleshooting, process optimization, and continuous improvement. This position will work closely with Manufacturing, Quality, Engineering, and other cross-functional teams to ensure processes are reliable, efficient, compliant, and capable of consistently meeting product and quality requirements.
Scope of Work / Key Responsibilities:
- Provide technical and sustaining engineering support for manufacturing processes and production operations.
- Develop, execute, and support process validation and qualification activities, including protocols, testing, data analysis, and final reports.
- Evaluate existing manufacturing processes and identify opportunities to improve quality, efficiency, process capability, production yield, and reliability.
- Troubleshoot manufacturing and process-related issues and lead or support root cause investigations.
- Recommend and implement process modifications and corrective actions based on technical and statistical analysis.
- Support the introduction, transfer, qualification, and optimization of new or modified manufacturing processes.
- Develop and maintain manufacturing process documentation, specifications, procedures, and engineering reports.
- Apply statistical techniques, including Statistical Process Control (SPC) and process capability analysis, to monitor and improve manufacturing performance.
- Support the selection, evaluation, and implementation of materials, tooling, fixtures, and equipment associated with manufacturing processes.
- Collaborate with Quality, Manufacturing, R&D, Operations, and other engineering functions to ensure processes meet established technical and quality requirements.
- Support CAPAs, deviations, investigations, change controls, and continuous improvement initiatives.
- Ensure manufacturing processes and validation activities comply with applicable GMP, quality system, and medical device regulatory requirements.
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Required Qualifications:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Chemical Engineering, or a related engineering discipline.
- Experience with process validation in a manufacturing environment.
- Strong troubleshooting, root cause analysis, and problem-solving skills.
- Ability to analyze process data and translate findings into practical manufacturing improvements.
- Strong communication and teamwork skills with the ability to work effectively across multiple functional areas.
- Experience working within a regulated manufacturing environment.
Preferred Qualifications:
- Previous experience in the medical device industry.
- Hands-on experience with process validation protocols and reports, IQ/OQ/PQ, and/or other qualification activities.
- Experience with SPC, process capability, DOE, or other statistical engineering tools.
- Knowledge of Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
- Experience supporting CAPAs, nonconformances, deviations, investigations, and change controls.
Top Candidate Priorities:
- Process Validation: Demonstrated hands-on experience with manufacturing process validation, preferably within the medical device industry.
- Problem Solving: Strong troubleshooting and analytical capabilities with experience identifying root causes and implementing effective solutions.
- Cross-Functional Teamwork: Ability to work effectively with Manufacturing, Quality, Engineering, and other stakeholders in a regulated manufacturing environment.
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Job Details:
Contract Duration: 1+ years
Location: On Site (South East, Puerto Rico)
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Why Apply?
This is a unique opportunity to work on a high-impact project in the pharmaceutical sector with a respected and growing firm. At SoltechPR, we value our people and are committed to offering meaningful work, professional development, and a supportive team environment. If you’re ready to bring your expertise to a major construction initiative in the regulated industry, we’d love to hear from you.
Apply today and become part of something impactful!