Manufacturing Engineer III

4 weeks ago

Cranbury, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • ssist in the remediation of identified gaps related to operations and packaging for EU MDR technical files from an engineering perspective.
  • Process engineering and project management to support remediation projects.
  • These projects are typically of increased complexity and can pose significant risk to product and processes if not designed and implemented correctly.
  • Complete projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting.
  • Must be able to perform/deliver specific project tasks as necessary
  • Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements (US FDA and ISO).
  • Coordinate specific efforts as required by the project team.
  • Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings.
  • Support projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
  • Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
  • s required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).
  • Participate and collaborate in technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
  • Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
  • Provide plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.
  • Provide technical input for analysis of process and equipment changes.
  • pply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing.
  • Evaluate and upgrade process equipment as required.
  • Execute other work as assigned by management
Requirements:
  • Bachelor's degree in engineering (Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Biomedical Engineering).
  • 3+ years of experience in manufacturing engineering within the medical device industry.
  • Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required.
  • Experience with Statistical Process Control tools required (SPC, Minitab, other software).
  • General chemistry, processing, and material expertise.
  • Considerable knowledge of the principles and practices of engineering as applied to various types of projects.
  • bility to prepare complex technical reports, project summaries, and correspondence.
  • Exceptional practical problem-solving skills, excellent organizational and communication skills.

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