Overview
Manufacturing Engineer Jobs in Texas, United States at United Pharma
Title: Manufacturing Engineer
Company: United Pharma
Location: Texas, United States
About the job:
We are seeking an experienced Manufacturing Engineer to support new product introductions, product transfers, process development, and manufacturing optimization within a regulated medical device manufacturing environment. This role will play a key part in ensuring manufacturing readiness, equipment qualification, process validation, and continuous improvement initiatives while supporting production growth and operational excellence.
Key Responsibilities:
• Lead and support New Product Introduction (NPI), technology transfer, and manufacturing scale-up activities
• Coordinate equipment procurement, installation, commissioning, and startup activities with suppliers and internal stakeholders
• Develop, execute, and approve validation protocols and reports including IQ, OQ, PQ, PPQ, and Test Method Validation activities
• Support process characterization, Design of Experiments (DOE), Gage R&R studies, and statistical analysis to improve manufacturing performance
• Design and implement manufacturing processes, tooling, fixtures, and equipment improvements to enhance efficiency and product quality
• Create and maintain manufacturing documentation including SOPs, work instructions, process specifications, and validation records
• Conduct root cause investigations, implement corrective actions, and support continuous improvement initiatives
Qualifications:
• Bachelor's Degree in Mechanical, Manufacturing, Industrial, Biomedical, or related Engineering discipline
• 5+ years of Manufacturing Engineering, Process Engineering, Product Development, or NPI experience
• Medical Device manufacturing experience required
• Strong experience with equipment qualification, commissioning, validation, and process development activities
• Hands-on experience with IQ/OQ/PQ, PPQ, TMV, DOE, and statistical analysis tools
• Knowledge of cGMP, ISO 13485, EHS, and regulated manufacturing environments
• Proficiency with Minitab, MS Project, Excel, Word, and PowerPoint
• Strong troubleshooting, technical writing, and project management skills
