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Primary Quality Engineer, New Product Development (1 of 2) - 2406196641W

Description

J&J MedTech a member of Johnson & Johnson's Family of Companies, 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/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Primary Quality Engineer, New Product Development, will be responsible for providing quality engineering support and leadership for New Product Development! In this role you will support 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. You will review and assess 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.

Key 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

Education:

• Bachelor’s degree or equivalent in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) related field.

Experience and Skills:

Required:

• A minimum of two (2) years of relevant work experience required three (3) years of relevant work experience preferred.

• Experience in the Medical Device Industry or other highly regulated field.

• New Product Development experience.

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

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.

• Solid understanding 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:

• This position will be located in Cincinnati, OH and may require up to 25% domestic or international travel.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-Ohio-Cincinnati

Organization Ethicon Endo Surgery Inc (6041)

Travel Yes, 25 % of the Time

Job Function R&D Mechanical Engineering

Req ID: 2406196641W