Senior Design Quality Engineer, MedTech NPD

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Parental Leave – 480 hours per year

Job summary

Johnson & Johnson MedTech is seeking a Senior Design Quality Engineer for New Product Development in Santa Clara, CA. The role leads quality engineering for NPD, ensuring GMP/ISO compliance and robust design controls.

The ideal candidate has 5+ years in quality, experience with NPD, and strong statistics knowledge. Travel up to 25% may be required for domestic and international coordination.

Qualifications

• Bachelor's Degree in Engineering from an accredited engineering school or related science field.
• 5+ years of quality experience.
• New product development experience.
• GD&T knowledge.
• Experience in medical device industry or other highly regulated field.
• Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity.
• Previous work experience in a team-based environment.

Responsibilities

• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Drives development of product requirements, verification strategies, and validation strategies.
• Ensures new product development compliance to GMP, ISO and applicable standards.
• Drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation documents for conformance.
• Develop inspection and sampling plans, test methods, and transfer functions for products and components.
• Support and expertise in developing and executing a reliability strategy during new product development.
• Conducts projects and assignments with technical responsibility.

Skills

New product development experience

GD&T knowledge

Experience in medical device industry

Advanced quality engineering methods

Analytical reasoning

Risk analysis

Education

Bachelor's Degree in Engineering or related science field

Job description

Johnson & Johnson MedTech is seeking a Senior Design Quality Engineer for New Product Development in Santa Clara, CA. The role leads quality engineering for NPD, ensuring GMP/ISO compliance and robust design controls.

The ideal candidate has 5+ years in quality, experience with NPD, and strong statistics knowledge. Travel up to 25% may be required for domestic and international coordination.