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Job Description:

The Staff Quality Engineer, Product Software Development, will provide quality leadership on new product project teams responsible for the development of medical device software systems. The Staff 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. 

DUTIES & RESPONSIBILITIES

• 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. Enhance processes to better reflect state of the art practices and drive continuous improvement. 

• 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, ISO13485, EU MDR, ISO14971, 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. 

• Additionally: 

• 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 

EXPERIENCE AND EDUCATION* 

• 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 6 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required.
• Experience with the development of Software as a Medical Device (SaMD) or System Development Life Cycle (SDLC) for medical device software is strongly preferred.
• Prior experience leading, coaching or mentoring other engineers or project core team members is required.
• Demonstrated ability to lead, synchronize, and motivate personnel both within and outside immediate control to meet goals and objectives.
• The ability to meet departmental goals/objectives is required.
• Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required. 
• Additional experience in functional areas outside of Quality (e.g. IT, Engineering, Software Development).
• Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements. 

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Ability to work in a team and demonstrate good interpersonal, organizational, and verbal/written communications skills.
• Extensive use of the personal computer and associated work tools (Word, Excel, Power Point) is required.
• Medical device industry experience.
• ASQ Certification as a Software Quality Engineer, or equivalent, is preferred.

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The anticipated base pay range for this position is :

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Company Name: Johnson & Johnson
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