Manufacturing Engineer III (Medical Device) - Intellectt INC

Role:Manufacturing Engineer III (Medical Device)
Location: Plainsboro, NJ - 08536
Duration: 6+ Months on W2
Work Hours: 8:30 AM to 5:00 PM (flexible)

Essential Duties and Responsibilities:

• Assist in identifying and remediating gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
• Support process engineering and project management for remediation projects, which may pose significant risks if not properly designed and implemented. Complete projects aimed at evaluating, analyzing, and improving existing processes, developing new manufacturing processes, and troubleshooting manufacturing issues.
• Ensure that all documentation, drawings, and specifications comply with Integra's procedures and statutory requirements (US FDA and ISO).
• Coordinate efforts within the project team, including developing manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO), and Engineering Drawings.
• Support projects in implementing statistical process control, analyzing and trending process parameters, and improving manufacturing yields while reducing scrap and error-proofing processes.
• Conduct timely technical investigations and provide practical manufacturing solutions within regulatory guidelines for medical device manufacture. Assist in conducting Non-Conformance Investigations and implementing corrective and preventive actions (CAPA support).
• Collaborate in technical teams across Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs for identified projects and products.
• Apply problem-solving skills to identify potential issues, assess their impact, and develop mitigation and resolution plans.
• Provide input on manufacturing process development, including process design requirements, risk analysis, and traceability matrices.
• Analyze process and equipment changes, providing technical insights.
• Lead the selection and/or design of equipment for prototype and full-scale manufacturing and evaluate process equipment as needed.
• Execute other tasks as assigned by management.

Desired Minimum Qualifications:

• Bachelor's degree in Engineering (Mechanical, Pharmaceutical, Chemical, Biomedical Engineering preferred).
• Experience in manufacturing engineering within the medical device industry.
• Knowledge of Quality System Regulations (QSR), Design Control, Process Validation guidelines, Engineering Change Controls, ISO standards, and regulatory guidelines is required.
• Experience with Statistical Process Control tools (SPC, Minitab, etc.) is essential.
• General knowledge of chemistry, processing, and materials.
• Strong understanding of engineering principles and practices across various projects.
• Proven ability to prepare complex technical reports, project summaries, and correspondence.
• Exceptional problem-solving skills, along with excellent organizational and communication abilities.