Sr Design Quality Engineer, Life Cycle Management

Johnson & Johnson•Irvine, CA

8d•$79,000 - $127,650•Hybrid

About The Position

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 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.

Requirements

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.

Nice To Haves

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).

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.

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year