Senior Design Quality Engineer, Digital Orthopedics

Company: Disability Solutions
Location: Boston
Posted on: February 1, 2025

Job Description:

Johnson & Johnson is seeking a Senior Design Quality Engineer, Digital Orthopedics to join the DePuy Synthes Digital, Robotics, and Capital Equipment team.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 Senior Design Quality Engineer 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 you'll act as a domain specialist for mechanical/electronic hardware of surgical robotics and capital equipment throughout the development lifecycle representing quality.In this role, 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. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, Integration, problem resolution and both Internal and External Audits.Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.Key Responsibilities:

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• 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.
• Identifies and implements 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.
• As necessary, lead complaint, NC, CAPA and product issue investigations as well as relevant supplier and health authority relationships
• Support internal audits and external audits by regulatory agencies, as required.\r\r

Keywords: Disability Solutions, Newton , Senior Design Quality Engineer, Digital Orthopedics, Engineering , Boston, Massachusetts