Manufacturing Engineer II

4 weeks ago

Plainsboro, United States Aditi Consulting Full time
Responsibilities:
  • Assist in the overhaul of the process related to the visual inspection of in process products s from an engineering perspective.
  • Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Visual Inspection
  • SME for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program
  • Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements
  • 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 Client's procedures and statutory requirements (US FDA and ISO).
  • Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).

Top 3 Skills:
  • Ability to prepare and execute engineering Studies, complex technical reports, project summaries, and correspondence.
  • Experience with Visual Inspection
  • Excellent Communication with ability to work well in a team environment.

Desired Qualifications:
  • 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.
  • Ability to prepare complex technical reports, project summaries, and correspondence.


Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

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