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
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Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine, California, United States of AmericaJob Description:
Johnson & Johnson Vision, a member of the Johnson & Johnson family of companies, is recruiting for a Sr Engineer Sr Engineer, NPI and Lifecycle Quality, located in Irvine, CA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Sr Engineer, NPI and Lifecycle Quality provides quality and technical leadership to ensure new and existing medical devices meet their intended use.
Key Responsibilities:
Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
Ensures effective risk management or product harms and hazards and improves capability of processes.
Leads development team in design control strategy and implementation
Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
Quality Management Systems support including Design Control, Risk Management, Change Control, Non-Conformance and
Corrective Actions and Audits.
Qualifications
Education:
Bachelors or equivalent university degree in Engineering or other related technical field is required.
Experience and Skills:
Required:
2-4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry.
Strong communication, interpersonal and organizational skills.
Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management.
Ability to function in a team environment and deliver on team objectives.
Strong attention to detail.
Strong written and verbal communication skills.
Developed presentation skills.
Preferred:
Experience in Medical Device industry.
Candidates should be familiar with general quality management system concepts, including good documentation practice
(GDP), corrective and preventive action (CAPA), and document change control practices
Human Factors Engineering experience.
Other:
Up to 10% domestic travel is required.
Relocation assistance will not be provided
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically SavvyThe anticipated base pay range for this position is :
$79,000.00 - $127,650.00Additional 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)).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
Skills Required
- Bachelor’s degree in Engineering or related technical field
- 2-4 years experience in Design/Process Engineering/Science/Statistics in a regulated industry
- Practical understanding of QSR/ISO medical device regulations, especially design controls and risk management
- Strong written and verbal communication and presentation skills
- Strong communication, interpersonal and organizational skills
- Ability to function in a team environment and deliver on team objectives
- Strong attention to detail
- Experience in Medical Device industry
- Familiarity with quality management system concepts including Good Documentation Practice (GDP), CAPA, and document change control practices
- Human Factors Engineering experience
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.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
