Senior Manufacturing Engineer I

- Mid Level

Plainsboro, NJ

Miscellaneous Manufacturing

About the position

The Senior Manufacturing Engineer will play a key role in driving manufacturing excellence, process improvement, and ensuring the highest quality standards in production operations. They will collaborate with cross-functional teams, including R&D, Quality Assurance, and Operations, to optimize manufacturing processes, troubleshoot technical issues, conduct root cause investigations, and implement corrective and preventive actions (CAPAs). Their expertise will contribute to the successful delivery of safe, effective, and reliable medical devices that comply with regulatory requirements.

Responsibilities

• Lead efforts to optimize manufacturing processes, including equipment selection, process flow, capacity planning, and cycle time reduction to maximize efficiency and productivity.
• Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing processes, ensuring compliance with regulatory standards.
• Coordinate specific efforts as required by the project team, including development of manufacturing process requirements, specifications, standard operating procedures (SOPs), Engineering studies, Engineering Change Orders (ECO) and Engineering Drawings.
• Lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Regulatory Affairs.
• Identify opportunities for process improvement and cost reduction through the application of Lean methodologies.
• Drive initiatives to enhance product quality, yield, and reliability.
• Provide manufacturing input and support for the successful transfer of new products and processes into production.
• Analyze and trend existing process parameters, process inputs and outputs to improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
• Conduct thorough investigations into nonconformances and product failures to identify root causes.
• Utilize problem-solving techniques (e.g., 5 Whys, fishbone diagrams) to determine corrective actions and implement preventive measures.
• Lead the implementation and tracking of CAPAs.
• Ensure timely completion of CAPA activities, including root cause analysis, action plan development, implementation, and effectiveness verification.
• Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO).
• Support internal and external audits to maintain compliance and address quality issues.
• Provide technical guidance and mentorship to junior engineers and manufacturing personnel.
• Execute other work as assigned by management.

Requirements

• Bachelor's degree in Engineering (Chemical Engineering, Biomedical Engineering). Advanced degree is a plus.
• 5+ years of experience or 3+ years with a Masters degree in engineering within the medical device industry.
• Solid understanding of manufacturing processes, including batch processing, packaging, and sterilization.
• Proficiency in process validation methodologies (IQ, OQ, PQ), statistical process control (SPC), and quality management systems.
• Experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Ability to prepare complex technical reports, project summaries, and correspondence.
• Familiarity with statistical tools (Minitab, Matlab, etc).
• Excellent problem-solving skills with a data-driven approach.
• Strong interpersonal and communication skills, with the ability to collaborate effectively across multidisciplinary teams.
• Knowledge of regulatory requirements and standards applicable to medical device manufacturing.
• Ability to manage multiple projects simultaneously and prioritize tasks effectively.
• Excellent analytical thinking and technical writing skills.
• Demonstrates leadership in groups and teams.