Supplier Engineer - Shockwave Medical

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

Supplier Engineer for Shockwave Medical at Johnson & Johnson, focusing on providing technical support to contract manufacturers and suppliers for the implementation and validation of manufacturing lines for medical devices. Responsibilities include process transfer, validation protocols, risk management, cost reduction, and quality improvement.

What you'd actually do

  1. Work collaboratively with our contract manufacturer and external partner to transfer and scale Shockwave manufacturing process.
  2. Supports development transfer activities from R&D & Operations to contract manufacturer/suppliers.
  3. Work with local, international suppliers and manufacturing sites to generate capacity/capability models and make vs. buy assessments used as an input to site planning.
  4. Perform validation protocols and completion of validation reports.
  5. Maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement preventive and corrective actions.

Skills

Required

  • Bachelor’s degree on Mechanical Engineering or related field
  • Experience in a medical device environment
  • Knowledge of lean manufacturing
  • Knowledge of design for manufacturability
  • Knowledge of test implementation
  • Strong problem solving and analytical skills
  • Experience with use of statistical analysis
  • Experience with design of experiments for product optimization and validation activities
  • Excellent organizational, verbal, and written communication skills
  • Attention to detail
  • Able to interface with all levels and functions of the organization
  • Cooperative team-balanced perspective

Nice to have

  • Proficiency in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R)
  • Knowledge with SolidWorks

What the JD emphasized

  • Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO and MDD requirements.) and other applicable regulations