DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, Product Software Development to be located in Warsaw, Indiana.
The DePuy Synthes Companies are part of the Johnson & Johnson Family of Companies. We offer one of the world’s most comprehensive portfolios of orthopaedic products and services in the areas of joint reconstruction, trauma, spine, sports medicine, cranio-maxillofacial, power tools and biomaterials. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care and keep people moving!
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. As a Staff Software Quality Engineer you 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 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 of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations.
- 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 62366-1.
- Provide technical support for audits of software suppliers and software consultants.
- He/she will be required to know, understand, incorporate and comply with all applicable laws and regulations relating to Depuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- A Bachelor’s 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.
- Prior experience coaching and mentoring other engineers or project core team members is required.
- Software as a Medical Device (SaMD) experience is strongly preferred.
- Confirmed ability to lead, synchronize, and motivate personnel both within and outside immediate control to meet goals and objectives
- The ability to utilize written and oral communication skills to meet departmental goals/objectives is required.
- Extensive use and knowledge of personal computer and associated work tools (Word, Excel, Power Point) is required.
- Medical device industry experience.
- ASQ certification as a Software Quality Engineer
- Additional experience in functional areas outside of Quality (e.g. IT, Engineering, Software Development)
- This position will be based in Warsaw, Indiana, and may require up to 10% domestic and/or international travel.
Medical Device Business Services, Inc (6029)