Sr. Engineer Production Engineering (m/f/d)

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

This role is for a Sr. Engineer in Production Engineering within the medical device industry. The primary focus is on overseeing and optimizing manufacturing processes, ensuring compliance with regulatory standards (ISO 13485, FDA), and driving continuous improvement. Key responsibilities include process design, optimization, troubleshooting, collaboration with cross-functional teams, process audits, root cause analysis, and ensuring compliance with GMP and safety regulations. The role requires a Bachelor's degree in Engineering or a related field with at least 5 years of experience in process management or engineering within the medical device sector. Experience with Lean Six Sigma and strong analytical skills are essential. The role is not directly AI/ML focused but operates within a regulated healthcare environment.

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. Lead 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, Biology, Biomedical Engineering, or a related field.
  • Minimum of 5 years of experience in process management or engineering within the medical device or related industry.
  • Strong knowledge of manufacturing processes, quality systems, and regulatory requirements in the medical device sector.
  • Proven experience with process optimization methodologies, such as Lean Six Sigma or other continuous improvement frameworks.
  • Strong 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

  • Advanced degree preferred.
  • Experience with project management and cross-functional team leadership.
  • Knowledge of risk management and validation processes associated with medical devices.
  • Familiarity with statistical process control (SPC) and other quality control techniques.
  • Agile Decision Making
  • Coaching
  • Corrective and Preventive Action (CAPA)
  • Critical Thinking
  • Emerging Technologies
  • Issue Escalation
  • Lean Supply Chain Management
  • Problem Solving
  • Process Control
  • Process Engineering
  • Product Costing
  • Product Improvements
  • Science, Technology, Engineering, and Math (STEM) Application
  • Situational Awareness
  • Technical Research
  • Technologically Savvy
  • Validation Testing
  • Vendor Selection

What the JD emphasized

  • ISO 13485
  • FDA regulations
  • GMP