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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 Sr. 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:
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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