DePuy Synthes, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Software Team Lead, Cyber Security & Robotics to be located in Boston, MA area.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.
The Software Team Lead, Cyber Security & Robotics will be a key supporting role in the team on the forefront of digital and robotic technology for the orthopedic medical device industry. This role will lead development of all aspects of Cyber Security. This role will also contribute to software documentation under regulation 62304 for the OS and clinical applications of the robotic system. The ideal candidate for this role is a strong collaborator that takes the time to understand the key stakeholders in order to drive improvements and efficiently complete all aspects of technical documentation, standards and procedures. They will have an extraordinary attention to detail on the project related to their responsibility area. Finally, they will have communication and collaboration skills that allow them to work within the software and greater R&D team and influence the cross functional teams to flawlessly execute on time and on scope.
In This Role You Will
- Plan, architect and document Cyber Security measures for software per FDA TIR57/97/NIST/UL2700.
- Manage operational and procedural aspects of the software project, ensuring all documentation and approvals are scheduled, tracked, current, stored and communicated appropriately per ISO 62304.
- Work closely the Sr. Software Manager, Software Managers, Team/Technical Leads and Software Quality to tie procedural program tracking to technical execution, quality requirements and documentation.
- Work closely with the Software Project Manager and Scrum Master ensuring the software program is aligned, documented and coordinated with the overall project program and timeline.
- Develop, maintain and track project timelines, cadence and stage gates that are part of the project plan.
- Identify assumptions, risks, mitigations, key deliverables, critical path dependencies and resource needs.
- Develop and present project updates, status reports, dashboard to communicate and track the project process, risk and mitigations to the team and to cross functional leadership.
- Show independent leadership of assigned project and team in a fast paced and dynamic environment.
- Deep understanding of medical device R&D processes over the product life cycle, from discovery to post marketing.
- A minimum of a Bachelor’s degree in a technical field is required.
- A minimum of 7 years of relevant work experience required.
- Full cycle software project management experience is required.
- Experience with software as a medical device is highly preferred.
- Preferred experience with 510K and CE marking standards for SaMD: ISO 62304, 14971, 60601, 13485.
- Experience with Cyber Security FDA TIR57/97/NIST/UL2700 is highly preferred.
- Position will be located in Boston, MA and may require up to 25% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
DePuySynthes Products Inc (6149)
R&D Engineering (R&D)
- Hospital & Health Care
- Medical Device
- Information Technology
- Salary Offer 0 ~ $3000
- Experience Level Junior
- Total Years Experience 0-5
- Dropdown field Option 1