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$125k–$201k/yr
Full-time
bachelor degree, postgraduate degree
Consolidated retirement plan, Savings plan (401k), Long-term incentive program, Vacation, Sick time, Holiday pay
Posted 2d ago
Apply by Sep 23
~40 hrs/week
Responsibilities
The Senior Design Quality Engineer will provide leadership and quality support throughout the new product development lifecycle, from concept to steady-state. They are responsible for ensuring compliance with regulatory standards, driving defect prevention, and managing verification and validation strategies.
Requirements
Candidates must hold a Bachelor's degree in Engineering or a related science field and possess at least 5 years of quality experience within a highly regulated industry. Proficiency in GD&T, applied statistics, and medical device design control requirements is essential for this role.
Full job description
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 Development
Job Sub Function:
R&D Software/Systems Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Santa Clara, California, United States of America
Job 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
The anticipated base pay range for this position is :
$125,000.00 - $201,250.00
Additional 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
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Health CareBiotechnologyMedicalManufacturingPharmaceuticalBiotech & PharmaceuticalsPharmaceutical and biotechnology
How much do Technology jobs in Santa Clara, CA pay?
Based on 2734 listings with disclosed salaries, most technology jobs in Santa Clara, CA pay between $116k–$288k per year. Individual offers vary with seniority, company size, and specialization.
How many Technology jobs are open in Santa Clara, CA right now?
There are currently 2,954 open technology positions in Santa Clara, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Technology roles in Santa Clara, CA?
Companies currently hiring include Applied Materials, NVIDIA, ServiceNow, AMD, Qualcomm, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Technology jobs in Santa Clara, CA?
Yes — 586 of the 2954 open technology positions offer remote or hybrid work (129 remote, 457 hybrid).
How do I apply for Technology jobs in Santa Clara, CA?
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