Staff Quality Engineer NPD (MedTech)

Location: Irvine, California, United States of America; onsite

Salary: $94,000–$151,800 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including products designed to make treatments smarter, less invasive, and more personal.

What you will do

• Lead quality assurance activities across the medical device product lifecycle, from new product development through manufacturing transfer and lifecycle management.
• Partner with R&D, Operations, Design, and other functions on engineering projects, quality processes, design verification, validation, and product testing.
• Develop risk management plans, including AFMEA, DFMEA, and PFMEA, and oversee quality-related non-conformance activities for U.S. facilities.
• Write, review, and approve validation protocols and reports, equipment qualifications, engineering change orders, and catheter test methods.
• Apply Six Sigma, SPC, DOE, Gauge R&R, ANOVA, and other statistical methods to assess data, acceptance criteria, and process capability.
• Resolve complex technical and compliance issues through failure analysis, root-cause investigation, and cross-functional project leadership.

Requirements

• Bachelor’s degree in engineering, science, or a related discipline; a master’s degree is preferred.
• At least 6 years of quality, manufacturing, or R&D experience in medical devices or another regulated industry.
• Knowledge of quality engineering, design control, verification and validation, quality management systems, GMP, and applicable regulatory requirements.
• Experience with risk management, Six Sigma or Design for Six Sigma, Lean manufacturing, DOE, DMAIC, ANOVA, and statistical problem-solving.
• Ability to lead and mentor employees, manage complex engineering projects, collaborate across functions, and communicate recommendations to management.
• Working knowledge of CAD tools such as SolidWorks or AutoCAD and GD&T according to ASME Y14.5.

Nice to have

• Experience with Minitab, R, or other statistical software.
• Master’s degree in an engineering or scientific discipline.

Culture & Benefits

• Inclusive work environment focused on respecting individual contributions, diversity, and dignity.
• Participation in retirement, pension, savings, and 401(k) plans, subject to plan terms.
• Eligibility for the company’s long-term incentive program.
• Paid vacation, sick time, holidays, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.
• Work is conducted in compliance with applicable health, safety, environmental, regulatory, and company requirements.