Senior Quality Engineer (NPD, MedTech)

Location: Santa Clara, California, United States of America

Salary: $125,000–$201,250 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of treatment and disease management.

What you will do

• Provide quality engineering support and leadership for new product development.
• Launch and stabilize products from concept and design through development and steady-state manufacturing.
• Develop product requirements, verification strategies, validation strategies, inspection plans, sampling plans, and test methods.
• Ensure compliance with GMP, ISO standards, design controls, manufacturing procedures, and validation requirements.
• Apply statistical methods and analytical problem-solving to product development and manufacturing.
• Support reliability strategies, risk management discussions, issue resolution, and continuous improvement.

Requirements

• Bachelor’s degree in engineering or a related scientific field from an accredited institution.
• At least five years of quality engineering experience and experience in new product development.
• Experience in the medical device industry or another highly regulated field.
• Knowledge of GD&T, quality engineering methods, scientific techniques, and applied statistics.
• Experience working in a team-based environment and ability to travel up to 25% domestically and internationally.
• Ability to work onsite in Santa Clara, California, United States.

Nice to have

• Advanced degree and experience with medical electrical-mechanical systems.
• Knowledge of FDA design control requirements and software verification and validation for medical electrical equipment.
• ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, or a Green Belt in DMADVV, DMAIIC, or Lean.
• Experience with product risk management and cascading product issues or hazards into potential user harms.
• Previous software quality engineering experience in a product development environment.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Eligibility for a consolidated retirement plan, pension, and 401(k) savings plan.
• Participation in the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.