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.