Design Quality Team Leader, Surgical Robotics.

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Job description

DePuy Synthes is seeking a Design Quality Team Leader, Surgical Robotics, to join our team in either the Boston, MA, Raynham, MA, West Chester, PA, Palm Beach Gardens, FL, OR Warsaw, Indiana sites!

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 .

In line with our dedication to our CREDO J&J offers excellent employee benefits including excellent health care, family leave, and retirement planning.

Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.

This individual is responsible for supporting product quality and reliability. They will ensure 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 other functions this individual will act as leader of a team of quality engineers responsible for mechanical / electronic hardware throughout the development lifecycle.

Key Responsibilities

• 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.
• Your team will also lead design transfer activities and ongoing supplier engagement.
• 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.
• The team leader will ensure training and development of their team.
• 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 align 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.
• Use 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.
• Other duties as required.
  
  

Education

Qualifications

• A minimum of a Bachelor of Science degree in Engineering, Electrical Engineering, or Biomedical Engineering, or other related degree is required
  
  

Required Qualifications

• A minimum of 6 years of Quality experience within the medical device, aerospace, defense, or other highly regulated industry with a focus on design control, risk management, and verification and validation
• Experience with the application of Data Science and Advanced Statistical Techniques
• Strong verbal and written communication skills; ability to present issues, plans and objectives
• Excellent interpersonal, problem solving, and analytical skills
• Previous experience leading engineering teams
• Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities
• Prior experience using Minitab, MS Teams
  
  

Preferred Qualifications

• Advanced Degree(s)
• 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
  
  

Other

• This position may require up to 10% domestic and international travel
• Ability to work at either the Boston, MA, Raynham, MA, West Chester, PA, Palm Beach Gardens, FL, OR Warsaw, Indiana sites is required
  
  

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.

Primary Location

United States-Massachusetts-Raynham-325 Paramount Drive

Other Locations

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

Organization

DePuy Synthes Products, Inc (6149)

Job Function

Engineering

Requisition ID

W