Production Engineer (m/f/d)

Johnson & Johnson Johnson & Johnson · Pharma · Aachen, North Rhine-Westphalia, Germany

Production Engineer role focused on optimizing manufacturing processes for medical devices, ensuring regulatory compliance (ISO 13485, FDA, GMP), and driving continuous improvement. Requires engineering degree and analytical skills. Preferred qualifications include project management and familiarity with risk management and SPC.

What you'd actually do

  1. Define, implement, and maintain manufacturing processes for medical devices, ensuring compliance with industry standards such as ISO 13485, FDA regulations, and other relevant guidelines.
  2. Work on process design and optimization efforts to improve efficiency, reduce waste, and enhance product quality.
  3. Troubleshoot process-related issues and implement corrective actions to minimize downtime and improve efficiency.
  4. Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure seamless integration of new products and processes into production.
  5. Conduct regular process audits and inspections to identify areas of improvement, ensuring adherence to established Standard Operating Procedures (SOPs).

Skills

Required

  • Bachelor’s degree in Engineering (preferably Production Technologies), Biomedical Engineering, or a related field.
  • Analytical skills with the ability to interpret data and drive decision-making based on insights.
  • Excellent communication, leadership, and interpersonal skills to effectively collaborate with cross-functional teams.

Nice to have

  • Experience with project management.
  • Familiarity of risk management and process validation associated with medical devices.
  • Familiarity with statistical process control (SPC) and other quality control techniques.
  • Analytical Reasoning
  • Computerized Equipment Skills
  • Corrective and Preventive Action (CAPA)
  • Emerging Technologies
  • Execution Focus
  • Gemba Kaizen
  • Issue Escalation
  • Lean Supply Chain Management
  • Process Control
  • Process Engineering
  • Process Oriented
  • Product Improvements
  • Project Engineering
  • Safety-Oriented
  • Science, Technology, Engineering, and Math (STEM) Application
  • Situational Awareness
  • Technical Research
  • Technologically Savvy

What the JD emphasized

  • ISO 13485
  • FDA regulations
  • GMP