Senior Design Quality Engineer — Medical Device NPD Leader

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

401(k) program

Pension plan

Paid time off 120 hours/year

Job summary

Johnson & Johnson in Santa Clara, CA seeks a Senior Design Quality Engineer for New Product Development to lead quality engineering in early-stage products. This role drives product quality strategy across development from concept to steady-state.

Responsibilities include defining verification/validation, ensuring GMP/ISO compliance, and collaborating with partners. A Bachelor’s in Engineering and 5+ years in quality, with GD&T and medical device experience, are required; travel up to 25% may be

Qualifications

• Bachelor’s degree in Engineering or related science from an accredited program.
• At least 5 years of quality experience in medical devices or regulated field.
• New product development experience.
• GD&T knowledge; applied statistics and quality engineering methods.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Define verification and validation strategies and product requirements.
• Ensure GMP/ISO compliance and drive defect prevention.
• Engage partners to drive consensus and resolve issues.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review design control, manufacturing, quality, engineering and validation documents for conformance.

Skills

Statistical methods

Quality engineering

GD&T knowledge

Problem solving

Teamwork

Design control knowledge

Education

Bachelor's Degree in Engineering or related science

Job description

Johnson & Johnson in Santa Clara, CA seeks a Senior Design Quality Engineer for New Product Development to lead quality engineering in early-stage products. This role drives product quality strategy across development from concept to steady-state.

Responsibilities include defining verification/validation, ensuring GMP/ISO compliance, and collaborating with partners. A Bachelor’s in Engineering and 5+ years in quality, with GD&T and medical device experience, are required; travel up to 25% may be