"Alerted.org

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:

R&D Product Development

Job Sub** **Function:

R&D 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 **Senior 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 Senior 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 Senior Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development.

Responsibilities:

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

+ 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.

+ Drive the development of product requirements, verification strategies, and validation strategies.

+ 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).

+ Develop a reliability strategy and lead reliability testing during new product development.

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

+ Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.

+ Proactively engage partners to ensure alignment and resolve issues in a timely manner.

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

Qualifications

Required:

+ Bachelor’s degree in engineering and/or equivalent scientific discipline

+ A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry

+ Advanced knowledge of Quality Engineering/Scientific methods and techniques and applied statistics of increasing complexity

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

+ Previous work experience engaging in a team-based environment

+ Ability to effectively collaborate and communicate with internal and external partners

+ Knowledge of Design for Reliability (DFR), defining reliability requirements and specifications, and development of reliability plans

+ Experience with Minitab, Reliasoft, or other statistical software

Preferred:

+ Advanced Degree

+ New product development experience

+ Experience with medical electrical-mechanical systems

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

+ Experience leading and/or supporting audits and regulatory discussions

+ 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)

+ 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.

Other:

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

+ The anticipated base pay range for this position is X to X