Sr Design Quality Engineer, Lifecycle Management

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 https://www.jnj.com

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 Neurovascular is recruiting for a Sr Design Quality Engineer, Life Cycle Management in Irvine, California.

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 position provides quality technical and compliance expertise as part of teams tasked with modifying existing designs, supplier changes, internal manufacturing support, and other lifecycle management activities. The use of engineering and supply chain knowledge to assist in the execution of cross-functional projects in support of the company’s strategies, goals, objectives, and product portfolio. Uses knowledge of scientific techniques and process excellence to modify/ develop and validate safe, effective, and efficient processes. Provides technical support to ensure continuity of supply. Assures compliance to applicable regulations and leads quality activities such as risk assessments, device testing, audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management, and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.

Responsible for supporting the Design Changes of products in compliance with the Cerenovus, Inc. Quality System and in line with Johnson & Johnson policies and standards to enable compliant growth and the design/manufacture of robust high-quality products. Works closely with the R&D, Regulatory, Supply Chain, Clinical and Marketing functions in creating/maintaining quality systems for product design and ongoing business needs.

Key Responsibilities:

Under limited supervision and in accordance with all applicable international, federal, state, and local laws/regulations/requirements and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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.

Qualifications

Education:

• A minimum of Bachelor’s or equivalent degree in Engineering or area of Scientific discipline is required; An advanced degree is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of professional 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 required (Microsoft Project, FPX and/or other project management tools).

Other:

• Travel, up to 10%, may be required.
• Role will follow the J&J Flex schedule of 2 days remote, 3 days on site.

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 (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is :

$77,000- $124,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation – up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.