Senior Design Quality Engineer, Digital Orthopedics (1 of 2)

Senior Design Quality Engineer, Digital Orthopedics (1 of 2) – 2406218014W

Description

Johnson & Johnson MedTech (a member of Johnson & Johnson Family of Companies) is currently seeking a Senior Design Quality Engineer, Digital Orthopedics to join our DePuy Synthes Digital, Robotics, and Capital Equipment team located in either Boston, MA, Warsaw, IN or Palm Beach Gardens, FL!

Per our J&J Flex Policy, the expectation for this position is to work in your assigned Johnson and Johnson office location 3-4 days per week and work from home 1-2 days per week.

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.

In this role you will support product quality and reliability, while ensuring the implementation and sustained support of groundbreaking technology for medical devices and digital health solutions is safe, effective, and follows regulations, standards, and industry practices. Working closely with multi-functional teams youll act as a domain specialist for mechanical/electronic hardware of surgical robotics and capital equipment throughout the development lifecycle representing quality.

You will help build, review and assesses product development results (e.g. user needs, design & development plans, usability, requirements, design documentation, risk management file, and verification & validation artifacts) to ensure that they align with applicable procedures, standards and regulatory requirements. You may also support other areas of the Quality Management System such as CAPA, Complaints, Integration, problem resolution and both Internal and External Audits!

Key Responsibilities:

Review all project / program work (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports). Provides direction and leadership for quality of digital health technologies.

Guide in establishing product and software requirements, specifications, detailed design, verification, validation, and usability protocols and planning documentation.

Collaborate with project and program teams to ensure results follow Johnson & Johnson MedTech procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance.

Provide Quality representation during problem resolution.

Participate in technical design reviews and project phase reviews.

Apply knowledge of risk management to ensure a risk-based approach for processes.

Identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.

Lead complaint, NC, CAPA and product issue investigations as well as relevant supplier and health authority relationships as needed.

Support internal audits and external audits by regulatory agencies, as required.

Qualifications

Education:

A Bachelor’s degree or University equivalent in Engineering (Electrical, Systems, Biomedical, Mechanical) or related scientific field required. Advanced degree preferred.

Experience and Skills:

Required:

A minimum of three (3) years of relevant experience with a focus on design control, risk management, and verification & validation.

A minimum of three (3) years Quality experience within the medical device, aerospace, defense or similarly regulated industry.

Experience with the application of Data Science and Advanced Statistical Techniques.

Strong verbal and written communication skills; ability to present issues, plans and objectives as well as excellent organizational, problem solving, and analytical skills

Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities.

Preferred:

Solid understanding of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles of Software validation.

Passion for development of new technologies, including the ability to apply design controls to emerging technologies

Other:

This position will be located in Boston, MA; Warsaw, IN or Palm Beach Gardens, FL and may require up to 10% 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-Boston-Massachusetts

Other Locations NA-US-Florida-Palm Beach Gardens, NA-US-Indiana-Warsaw

Organization DePuy Synthes Products, Inc (6149)

Travel Yes, 10 % of the Time

Job Function R&D/Scientific Quality

Req ID: 2406218014W