Sr Eng RD Soft Eng

R&D Product Development

R&D Software/Systems Engineering

Scientific/Technology

Boston, Massachusetts, United States of America

Senior Quality Engineer, Product Software Development Synthes or DePuy;
West Chester, PA or Warsaw, IN or Raynham, MA or Palm Beach Gardens, FL or Rheinsheim, Germany

The Senior Quality Engineer, Product Software Development, will provide quality leadership on new product project teams responsible for the development of medical device software systems. The Senior Quality Engineer will be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.

• Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
• Provide leadership, guidance and expertise on the software development process, procedures and practices
• Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive.
• Facilitate the documentation and tracking of verification activities, including code review findings.
• Review test case execution results and manage defects.
• Facilitate software risk assessment sessions and own the development of risk documents.
• Support regulatory filings and registrations.
• Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
• Provide technical support for audits of software suppliers and software consultants.
• Conduct training on Medical Device Software development processes and quality systems.
• Train and mentor new engineers and lower-level quality engineers.
• Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO
  13485, EU MDR, ISO
  14971, IEC 62366, ISO 27001, and HIPAA.
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures, as well as medical device regulations.
• Ensure that patient’s ePHI and PII data is protected and security requirements are met.
• Know, understand, incorporate and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures for Health Care Compliance Program and Code of Conduct.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

• A bachelor’s degree or university degree is required. An advanced degree is preferred.
• Degrees in Engineering, Computer Science, Information Systems, Biomedical/Bio-engineering Degree preferred.
• A minimum of 4 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.
• The ability to apply appropriate Quality tools/systems/processes to meet departmental goals and objectives as required.
• Demonstrated ability to prioritize and manage multiple projects while meeting…