Staff Manufacturing Engineer - Shockwave

Johnson & Johnson

Santa Clara, California, United States of America
Base: $105,000 to $169,050 annually; bonus: eligib...
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Bachelor's degree in mechanical or biomedical engineering
8 years experience in medical device environment
Knowledge of fda qsr, iso, mdd regulations
** Johnson & Johnson is seeking a Staff Manufacturing Engineer for its Shockwave Medical team in Santa Clara, CA. The role involves designing and implementing manufacturing processes for innovative medical devices aimed at treating cardiovascular diseases. **

Job Summary

  • The Staff Manufacturing Engineer will design, develop, and implement processes and tooling for Shockwave Medical's Intravascular Lithotripsy products.
  • Candidates must possess a minimum of eight years of experience in the medical device industry with knowledge of FDA and ISO regulations.
  • The role offers a competitive base salary range of $105,000 to $169,050 annually along with performance bonuses and comprehensive benefits.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Staff Manufacturing Engineer for its Shockwave Medical team in Santa Clara, CA. The role involves designing and implementing manufacturing processes for innovative medical devices aimed at treating cardiovascular diseases. **

Salary

Base: $105,000 to $169,050 annually; Bonus: Eligible for annual performance bonus based on individual and corporate targets; Benefits: Medical, dental, vision, life insurance, 401(k), and paid time off included

Skills & Requirements

Must-have

  • Bachelor's degree in Mechanical or Biomedical Engineering
  • 8 years experience in medical device environment
  • Knowledge of FDA QSR, ISO, MDD regulations
  • Experience with Process Validations IQ OQ PQ
  • Proficiency in Solidworks and Minitab software
  • Ability to perform tolerance analysis and DOE planning

Nice-to-have

  • Lean Manufacturing and 6S methodology experience
  • DMAIC problem solving leadership skills
  • Strong written and verbal communication abilities
  • Flexibility to work in fast-paced environments
  • Supplier selection and technical development support

Key Requirements

  • Bachelor's degree in Mechanical or Biomedical Engineering
  • Minimum 8 years medical device experience
  • Compliance with QSRs, FDA, ISO, MDD regulations
  • Process Validation (IQ, OQ, PQ) expertise
  • Statistical software proficiency (Minitab)

Work Rights

Not specified

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