Johnson & Johnson · 6 hours ago
Sr Design Quality Engineer, Life Cycle Management
Irvine, California, United States of America
Full-time
Hybrid
Mid, Senior Level
$79K/yr - $128K/yr
4+ years expJohnson & Johnson is a leader in healthcare innovation dedicated to improving patient outcomes. They are seeking a Sr Design Quality Engineer for Life Cycle Management who will provide quality technical expertise and support cross-functional projects related to product design and manufacturing processes.
Hospital & Health Care
Responsibilities
Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the quality system
Executes Life Cycle Management projects in a cross-functional setting as the design quality engineer core team member
Works on complex problems and provides solutions which are highly innovative and comprehensive
Applies scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations
Works independently and in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for design, process, and manufacturing related issues
Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Owns Post Market surveillance activities
Evaluates manufacturing processes / products and collaborates with R&D, NPI, Sourcing, QA, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs
Utilizes the application of six sigma and lean tools and methodologies
Ensures quality conduct of projects including design, data summary and interpretation, reports and review compliance to applicable regulations
Generate written reports and provide technical expertise to related projects
Provide technical support for outside suppliers, vendors, and/or consultants as required
Provide guidance and work direction to other engineers and related project team members
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures
Performs other duties assigned as needed
Qualification
Required
A minimum of Bachelor's or equivalent degree in Engineering or area of Scientific discipline is required; An advanced degree is preferred
A minimum of 4 years of related experience
Knowledge working in a highly regulated industry
Familiarity with ISO 13485, specifically Design Control
Interpersonal skills that promote conflict resolution in both personnel and technical contexts
Strong written and verbal communication skills to communicate effectively at all levels
Excellent problem solving/root cause investigation and decision-making skills
Preferred
Medical device industry experience
Manufacturing process IQ, OQ, PQ qualifications as related to medical devices
Working knowledge of applicable requirements related to the MDSAP jurisdictions
Strong project management skills (Microsoft Project, FPX and/or other project management tools)
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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