DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Product Software Quality Engineer (QE), Staff , located in West Chester, Pennsylvania.
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 Staff Product Software Quality Engineer will provide quality leadership on new product project teams responsible for the development of medical device software systems. As a Product Software Quality Engineer (QE), Staff, 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, testing and maintenance 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 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 IEC 62304, FDA QSR and Guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, and IEC 62366-1
- Provide technical support for audits of software suppliers
- Know, understand, incorporate, and follow 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/Bioengineering preferred.
Experience and Skills
- A minimum of 6 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity
- A minimum of 2 years of Medical Device Software quality experience
- FDA 820 Quality System Regulation, Design Controls, and IEC 62304 expertise
- Prior experience leading, coaching and mentoring other engineers or project core team members
- Confirmed ability to lead, synchronize, and empower personnel both within and outside immediate control to meet goals and objectives
- Excellent written and verbal communication skills
- Extensive use and knowledge of personal computer and associated work tools (Word, Excel, Power Point) is required.
- Experience with Software as a Medical Device (SaMD)
- Systems Engineering experience or training
- ASQ certification as a Software Quality Engineer
- Additional experience in functional areas outside of Quality (e.g., IT, Engineering, Software Development)
- This position may require up to 10% domestic and/or international travel
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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.