Principal R&d Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Groningen, Netherlands

This role is for a Principal R&D Engineer at Johnson & Johnson's Vision division in Groningen, Netherlands. The primary focus is on designing, developing, and improving medical devices, products, and processes, ensuring compliance with Design Control regulations and cGMP. Responsibilities include leading projects, conducting validation and verification studies, performing risk and root cause analysis, and collaborating with cross-functional teams. The role requires experience in highly regulated industries like medical devices or pharma, with a strong emphasis on problem-solving methodologies and statistical analysis.

What you'd actually do

  1. Develop, improve and characterize products, processes, equipment, test methods and procedures and define requirements
  2. Lead in planning and execution of development projects, project design reviews (Design Control) and project gate reviews and close projects with predefined effectiveness checks.
  3. Lead engineering, validation and verification studies by setting up a test plan and protocol, test criteria, performing tests, analyzing, interpreting and reporting outcomes as well as identifying and solving technical issues.
  4. Plan, coordinate and evaluate the implementation of new or modified products and processes, including the creation of protocols, reports and procedures, risk assessments and performing training of employees.
  5. Analyze and assess product and process requirements (materials, process, quality, EHS, product specifications) and perform risk and root cause analysis

Skills

Required

  • Master of Science or Engineering in relevant subject with minimal 6 years of professional experience in a highly regulated industry like medical device or Pharma OR Bachelor of Science or Engineering in relevant subject with minimal 8 years of professional experience in a highly regulated industry like medical device or Pharma
  • Experienced in leading multidisciplinary projects or complex projects with significant business impact.
  • Demonstrated knowledge in problem-solving methodology (DOE, Process Capability Analysis, Hypothesis Test Methods).
  • Proficient in applying statistical methodologies and analysis using Minitab.
  • Excellent verbal and written proficiency (at least at B2 level) in English

Nice to have

  • Dutch knowledge
  • Knowledge of process validation and/or systems validation.
  • Proficient in the use of Microsoft Project.
  • Analysis of complex datasets using Python or MatLab.
  • Knowledge of high precision injection molding technology.
  • Experience in rapid prototyping

What the JD emphasized

  • Design Control
  • cGMP
  • ISO
  • risk analysis
  • root cause analysis
  • process validation
  • systems validation