J&J Family of Companies Design Quality Engineer, Digital Orthopedics in Palm Beach Gardens, Florida
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies is currently recruiting for a Design Quality Engineer, Digital Orthopedics. The preferred location is Boston, MA, with consideration for one to be based in West Chester, PA, Palm Beach Gardens, FL, Raynham, MA, or Warsaw, IN.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com
Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.
This Design Quality Engineer, Digital Orthopedics is responsible for supporting product quality and reliability 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 this individual will act as a domain specialist for mechanical / electronic hardware throughout the development lifecycle. The individual reviews and assesses product development results (e.g., user needs, design & development plans, 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, problem resolution and both Internal and External Audits.
Review all project / program deliverables (e.g., plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
Provides direction and leadership for verification and validation of digital health technologies. Guide in establishing product and software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
Collaborate with project and program teams to ensure results comply with DePuy Synthes 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 Utilize knowledge of risk management to ensure a risk-based approach for QMS 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.
Support internal audits and external audits by regulatory agencies, as required.
A minimum of a Bachelor of Science degree in Engineering, Electrical Engineering, or Biomedical Engineering, or relevant degree is required
Required Skills & Experience:
A minimum of 2 years of demonstrated ability with a focus on design control, risk management, and verification and validation
A minimum of 2 years of Quality AND/OR Electrical Engineering experience within the medical device, aerospace, defense, or similarly regulated industry
Strong verbal and written communication skills; ability to present issues, plans and objectives
Excellent organizational, problem solving, and analytical skills
Ability to contribute to, demonstrate flexibility, and a willingness to work within constantly evolving priorities
Preferred Skills & Experience:
Experience with the application of Data Science and Advanced Statistical Techniques
Working knowledge 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
The preferred location is Boston, MA, with consideration for one to be based in West Chester, PA, Palm Beach Gardens, FL, Raynham, MA, or Warsaw, IN.
This position may require up to 10% domestic and 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.
United States-Massachusetts-Raynham-325 Paramount Drive
North America-United States-Massachusetts-Boston, North America-United States-Indiana-Warsaw, North America-United States-Pennsylvania-West Chester, North America-United States-Florida-Palm Beach Gardens
DePuy Synthes Products, Inc (6149)
J&J Family of Companies
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