Sr Eng RD Soft Eng

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Software/Systems Engineering Job Category: Scientific/Technology All Job Posting Locations: Boston, Massachusetts, United States of America Job Description: Job Description 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 SECTION 1: JOB SUMMARY* 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. SECTION 2: DUTIES & RESPONSIBILITIES* Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position has the following 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 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: o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed SECTION 3: 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 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 deadlines/budgets is required. · Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements. SECTION 4: 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. SECTION 6: ADDITIONAL POSITION REQUIREMENTS This position reports to the Manager or Senior Manager of Quality Engineering · Potential internal interfaces that this role may encounter include:o Interfacing with other Quality Team memberso Working with Research & Development on product issueso Working with Product Owners on product requirementso Working with Program Management on product scheduleso Working with other product teams to support other products or platformso Working with other supporting teams such as Product Security, Regulatory Affairs, Medical Affairs, Medical Safety, Customer Support, Product Complaints, Privacy, Legal, Independent Reviewers, etc. for review and approval of design history file (DHF) documentation