Staff Design Quality Engineer, Life Cycle 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:

Raynham, Massachusetts, United States of America

Job Description:

Johnson & Johnson Neurovascular is recruiting for a Staff Design Quality Engineer, Life Cycle Management in Raynham, Massachusetts.

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 establishing customer needs, developing new products and/or modifying existing designs. 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