Sr Engineer, NPI and Lifecycle Quality

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job 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 ra