IBM Watson Health - Design Assurance Engineer in Raleigh, North Carolina
*New hires can join in a Watson Health strategic location. RTP, NC; Cambridge, MA; North Castle, NY are preferred.It’s time to transform health with new ways of working to improve approaches to care, productivity and well-being. Watson Health’s cognitive systems understand, reason and learn – helping to translate information into knowledge that can help drive more informed decision-making. With cognitive computing, we can see and analyze more data than ever before – and achieve more than we ever thought possible. As a Design Quality Assurance Engineer and member of the Watson Health Compliance Organization you will work in a multi-disciplinary group, contributing to the design and development of Software Systems and verification processes for the development of Class I, II and III medical devices, including new product development and maintenance of released product. You will use your knowledge of FDA Pharmaceutical and Medical Device compliance regulations and international standards to provide design quality assurance support for Clients, Project Leaders, Development, Operations, and other cross-functional team members and personnel. You will support post market surveillance processes for Watson Health. This will include participation in resolving CAPAs, complaints, MDRs, recalls, serving and non-conforming products. You will interface with the Business and Marketing leaders, the solution reams, compliance organization, the legal department and other stakeholders to maintain compliance of Watson Health Offerings.You will be responsible for:
Providing design quality assurance support in the development of medical device products, and facilitating the application of design controls and V&V system/software validation.
Providing design assurance support for post market surveillance processes when design changes are required.
Ensuring development activities are planned, documented, and executed to satisfy regulatory, customer and designated internal requirements.
Ensuring development is compliant with internal and external standards
Actively supporting product development projects by coaching teams to create Project Development Plans, Design Inputs and Outputs, Design History Files, Risk Management, Test strategy, Verification and Validation plans, Test Traceability, etc.
Participating in product risk assessment efforts, including hazard analysis and design failure mode effect analysis
Reviewing and approving design verification and validation test plans, protocols and reports.
Ensuring changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
Participating in continuous improvement of design control process and project management planning
Ideally, you will be:
Current in knowledge of applicable federal and state healthcare regulations, laws and accreditation standards
Experienced in compliance laws and regulations, access, release of information, and release control technologies including 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485, ISO 14971, IEC 62304 and the Medical Device Directive
Knowledgeable of verification and validation in a regulated industry
Skilled in requirements analysis, including testable and measurable specifications
Experienced with standards for the design, verification, and validation of medical device products
Join us and be part of a diverse and global team of thinkers and doers — people who want to make an impact, cultivate their expertise and collaborate with some of the world’s top business and technology professionals.
- At least 5 years of work experience in a healthcare device or life sciences pharmaceutical company