J&J Family of Companies Staff Quality Engineer, Product Software Development (Orthopedics Robotics) (1 of 2) in Boston, Massachusetts
DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, Product Software Development (1 of 2) to be located in Boston, Massachusetts.
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.
Key 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.
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, and 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
A Bachelor’s Degree is required; An Advanced Degree is preferred
Degrees in Engineering, Computer Science, Information Systems, Biomedical/Bioengineering Degree preferred
Experience and Skills: Required:
A minimum of 6 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity
Medical Device industry experience
Prior experience leading, coaching and mentoring other engineers or project core team members
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
Extensive use and knowledge of personal computer and associated work tools (Word, Excel, Power Point)
Experience with Software as a Medical Device (SaMD)
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 Boston, Massachusetts, and may require up to 10% domestic and/or international travel.
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.
DePuy Synthes Products, Inc (6149)
J&J Family of Companies
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