Leads design quality engineering for medical device new product development, from concept through launch and steady-state. Develops product requirements, verification and validation strategies, inspection and sampling plans, test methods, reliability strategies, and risk-management approaches. Ensures compliance with GMP, ISO, FDA design controls, and internal procedures while supporting statistical analysis, defect prevention, continuous improvement, and document approvals. Requires collaboration across engineering, manufacturing, quality, and validation teams, with up to 25% domestic and international travel.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
R&D Product DevelopmentJob Sub Function:
R&D Software/Systems EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob Description:
The Senior Design Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.
Responsibilities:
- Launch and stabilize new product launches through concept, design, development, and steady-state processes.
- Drives the development of product requirements, verification strategies, and validation strategies.
- Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
- Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Proactively engage partners to drive consensus and resolve issues in a timely fashion.
- Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
- Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
- Develop inspection and sampling plans, test methods, and transfer functions for products and components.
- Provide support and expertise in developing and executing a reliability strategy during new product development.
- Conducts projects and assignments with technical responsibility.
Basic Qualifications
Required:
- Bachelor’s Degree in Engineering from an accredited engineering school or related science field
- At least 5 years of quality experience
- New product development experience
- GD&T knowlegde
- 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 engaging in a team-based environment
- Ability to travel up to 25% Moderate domestic and international
Preferred:
- Advanced Degree
- Experience with medical electrical-mechanical systems
- Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Prior software quality engineering experience in a product development environment
Required Skills:
Preferred Skills:
Analytical Reasoning, Quality Compliance, Quality Control (QC), Quality Planning, Quality Tools, Quality Validation, Risk AnalysisThe anticipated base pay range for this position is :
$125,000.00 - $201,250.00Additional Description for Pay Transparency:
Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.[DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION]
Please use the following language:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
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