Process Engineer

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.