Senior Quality Engineer NPD (MedTech)

Location: Irvine, California, United States of America

Salary: $79,000–$127,650 per year

Company

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

What you will do

• Plan, coordinate, and execute quality assurance activities across the medical device product lifecycle.
• Support new product development with R&D, Operations, and Design teams, including design verification, product testing, process validation, and manufacturing transfer.
• Develop risk management plans, including AFMEA, DFMEA, and PFMEA, and oversee the Quality NPD Non-Conformance Report process for U.S. facilities.
• Write, review, and approve validation protocols and reports, equipment qualifications, engineering change orders, and quality system documentation.
• Analyze data using Six Sigma, SPC, DOE, Gauge R&R, ANOVA, and sample-size determination to assess process capability and acceptance decisions.
• Lead technical problem-solving, failure analysis, root-cause investigations, and complex engineering projects while providing quality expertise and coaching to other engineers.

Requirements

• Bachelor’s degree, preferably in engineering or a scientific discipline, or at least four years of quality, manufacturing, or R&D experience in a medical device or other regulated industry.
• Experience with quality engineering, design controls, verification and validation, regulatory requirements, and quality systems including GMP.
• Knowledge of DOE, DMAIC, ANOVA, Six Sigma or Design for Six Sigma, process excellence, and lean manufacturing.
• Demonstrated auditing, analytical reasoning, problem-solving, project management, collaboration, communication, and influencing skills.
• Working knowledge of CAD software such as SolidWorks or AutoCAD, dimensioning, tolerance stack analysis, and GD&T in accordance with ASME Y14.5.
• Ability to work at the Irvine, California location.

Nice to have

• Experience with Minitab, R, or other statistical software.
• Additional experience with SolidWorks or other CAD-based programs.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and employee contribution.
• Eligibility for pension and 401(k) savings plans.
• Participation in the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off, subject to applicable policies.