Join a high-performing team at a global leader in medical device manufacturing. We're seeking a skilled and driven Process Engineer to lead critical initiatives focused on optimizing manufacturing processes and introducing new technologies. This is a 12-month contract opportunity with the potential to make a lasting impact on patient outcomes through enhanced product quality and process efficiency.
Key Responsibilities:
Process Development & Optimization:
* Lead investigations into process performance, identify root causes of issues, and implement corrective actions.
* Drive continuous improvement initiatives to enhance process capability, yield, and efficiency.
* Support validation activities including process qualification, equipment validation (IQ/OQ/PQ), and test method validation.
New Product Introduction:
* Collaborate with R&D, Quality, and Manufacturing teams to ensure seamless integration of new products into commercial production.
* Support process development, scale-up activities, and manufacturing readiness for product launches.
Documentation & Compliance:
* Develop and update technical documentation, including manufacturing instructions, process flows, risk assessments, and validation protocols.
* Ensure all activities comply with FDA regulations, ISO standards, and internal quality systems (QMS).
Troubleshooting & Technical Support:
* Provide front-line technical support to manufacturing operations.
* Perform root cause analysis and implement effective long-term solutions.
Project Management:
* Support capital equipment projects including process definition, vendor engagement, and installation.
* Coordinate with suppliers, contractors, and internal teams to meet project milestones and quality requirements.
Specific Education & Experience Requirements:
* Degree in Engineering (Mechanical, Biomedical, Chemical, or related field).
* 3+ years' experience in a regulated manufacturing environment, preferably medical devices or pharmaceutical.
* Strong understanding of FDA regulations, ISO 13485, and cGMP principles.
* Demonstrated experience in process validation, statistical analysis (DOE, SPC), and technical problem solving.
* Experience with equipment installation, process automation, and lean manufacturing principles is desirable.
* Excellent communication and cross-functional teamwork skills.
* Familiarity with Design Control and Risk Management (FMEA, pFMEA) processes.
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