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Production Process Engineer

2 months ago

Grand Rapids, Michigan, United States Novozen Healthcare LLC Full time

Job Title: Manufacturing Engineer

Key Responsibilities:

  • Formulate and implement corrective action plans to resolve compliance issues associated with manufacturing processes.
  • Work collaboratively with interdisciplinary teams to devise comprehensive action plans and schedules for resolution.
  • Guarantee prompt and effective execution of corrective measures to adhere to regulatory standards.
  • Direct and carry out action plans for process controls to uphold manufacturing quality and uniformity.
  • Establish monitoring frameworks to oversee process parameters and identify discrepancies.
  • Facilitate training sessions for personnel on newly introduced or revised process controls.
  • Regularly evaluate the efficacy of process controls and initiate enhancements as necessary.
  • Revise documentation for all manufacturing processes within PLM systems, ensuring precision and compliance.
  • Maintain accurate records of modifications, updates, and versions of manufacturing documentation.
  • Assist in projects aimed at improving labeling systems by contributing to the design and implementation of upgraded labeling solutions.
  • Collaborate with IT and quality assurance teams to enhance labeling software and data management systems.
  • Devise and execute procedures for labeling that guarantee accuracy and adherence to regulatory standards.

Skills and Qualifications:

  • Robust understanding of manufacturing processes, especially in relation to production.
  • Experience in designing and refining line layouts for manufacturing processes.
  • Demonstrated experience in developing and validating manufacturing processes for efficiency and compliance.
  • Familiarity with CAPA processes for addressing and preventing quality challenges.
  • Ability to perform thorough root cause analysis and implement corrective measures.
  • Expertise in identifying root causes of process challenges and formulating practical solutions.
  • Experience with Gemba walks to observe and enhance manufacturing processes.
  • Dedication to continuous improvement through Lean, Six Sigma, or other quality methodologies.
  • Six Sigma certification (Green Belt or Black Belt) is advantageous.
  • Comprehensive understanding of manufacturing and labeling requirements specific to medical devices.
  • Awareness of regulatory standards such as FDA and ISO for medical device manufacturing.
  • Knowledge of global manufacturing regulations, including ISO, FDA, and other pertinent standards.
  • Experience in ensuring manufacturing processes and documentation comply with regulatory requirements.

Educational Requirements:

  • Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Packaging Engineering, or a related discipline.
  • Advanced degrees or certifications in relevant fields are beneficial.

Experience Requirements:

  • Years of experience in manufacturing engineering, preferably within the medical device sector.
  • Experience with PLM systems and quality management systems is highly desirable.