Staff Manufacturing Engineer, IVL Shockwave

Johnson and Johnson; California (MO); On-site; USD 105,000 - 169,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Paid vacation

Job summary

Johnson & Johnson is hiring a Staff Manufacturing Engineer, Shockwave Medical, for our Santa Clara, CA team. This role focuses on designing, validating, and implementing manufacturing processes and tooling across the product lifecycle.

The ideal candidate has extensive experience with process validations, Lean methods, and data-driven problem solving in a medical device environment. Collaboration with R&D, QA and Operations is essential.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 8+ years in medical device or similar regulated environment or 6 years with a Master’s degree.
• Knowledge of QSRs, FDA, ISO and related regulations.
• Experience with Process Validation (IQ/OQ/PQ), 6S and Lean Manufacturing.
• Experience using statistics, capability studies (Cpks), and DOE analysis.
• Strong written and verbal communication; capable of presentations.
• Proficient with SolidWorks, Minitab or equivalent.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Collaborate with R&D, QA and Production to design, develop, test and implement processes, tooling and fixtures.
• Collect data and analyze process performance for products in development and production.
• Perform tolerance analysis for components, materials, packaging and in-house processing.
• Lead PFMEAs for processes and maintain design documentation and lot history records.
• Develop user requirements, specifications and design documents.

Skills

Statistical analysis

DMAIC problem solving

Project management

Communication

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Minitab

DOE

Job description

Johnson & Johnson is hiring a Staff Manufacturing Engineer, Shockwave Medical, for our Santa Clara, CA team. This role focuses on designing, validating, and implementing manufacturing processes and tooling across the product lifecycle.

The ideal candidate has extensive experience with process validations, Lean methods, and data-driven problem solving in a medical device environment. Collaboration with R&D, QA and Operations is essential.