• Primary Quality Engineer

    J&J Family of Companies (Cincinnati, OH)


    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:

    Mechanical Engineering

    Job Category:

    Scientific/Technology

    All Job Posting Locations:

    Cincinnati, Ohio, United States of America

    Job Description:

    Job Description

    J&J MedTech is recruiting for a **Primary Quality Engineer, New Product Development** , located in **Cincinnati, OH.**

     

    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/.

     

    The Primary Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. The individual reviews and assesses development activities (e.g., user needs, development / quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.

     

    The Primary Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.

    Responsibilities:

    + Support launch and stabilize new products through concept, design, development, and steady-state processes.

    + With support from more experienced Quality Engineers, drive the development of product requirements, verification strategies, and validation strategies.

    + Provide statistical support and analytical problem solving for product development and manufacturing.

    + Ensures new product development is compliant to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), and all other applicable standards.

    + Review and approve design control, manufacturing, quality, engineering, and validation / qualification documents to ensure conformance to business practices and departmental procedures.

    + Support the Risk Management Process per ISO 14971 by constructing / maintaining the Risk Management File (Including but not limited to: design, process, and use FMEAs).

    + Provide support in developing a reliability strategy during new product development.

    + Develop inspection and sampling plans for components and finished products.

    + Technical problem solving, failure analysis, and root cause investigation/determination.

    + Proactively engage partners to drive consensus and resolve issues in a timely fashion.

    + Conducts projects and assignments with technical responsibility based on mentorship from more senior QE.

    Qualifications:

    Required:

    + Bachelor’s Degree in Engineering from an accredited engineering school or related science field.

    + 2 years of related work experience.

    + Experience in medical device industry or other highly regulated field.

    + New product development experience.

    + Previous work experience engaging in a team-based environment.

    + Ability to travel up to 25% domestic and international.

    Preferred:

    + Experience with medical electrical-mechanical systems.

    + Knowledge of FDA requirements for design control of medical devices, particularly with verification and validation of software for medical electrical equipment.

    + ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean).

    + Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.

    + Prior software quality engineering experience in a product development environment.

    + Experience with Minitab, Reliasoft, or other statistical software

    + Working knowledge of SolidWorks, other CAD based programs (ie. basic dimensioning, tolerance stack analysis).

    + Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.