Full-stack Engineer

• Provide product development engineering subject matter expertise to enable optimization of drug administration into tumors in clinical trial sites.
• Work with healthcare practitioners and our Clinical and Marketing teams to align on the Target Product Profile, grounded in deep insight into unmet needs for intra-tumoral drug delivery procedures.
• Actively contribute to solution strategy decision-making by providing relevant research, analysis and expertise to address the intra-tumoral procedural needs, balancing near-term clinical trial deliverables with long-term commercial goals.
• Collaborate with a cross-functional team spanning across sectors (Medical Devices and Pharmaceuticals) and with functions including CMC, Clinical, Discovery, Regulatory, Quality, Project Management, Finance, Legal, and others.
• Leverage external (outside J&J) development and manufacturing partners to achieve project deliverables in a timely and cost-effective manner.
• Supervise creation of design control and risk management documentation to support regulatory filings for investigational devices used in investigational drug trials.
• Guide teams through risk/benefit tradeoff decisions, proactively identifying risks and proposing mitigation solutions.
• Develop and maintain project plans and budgets to ensure timely delivery of new products.
• Attend key scientific conferences and engage KOLs to build a deep clinical understanding of intra-tumoral injection procedures, emerging areas of research, regional and site-specific regulations and policies, and the potential benefits of new technologies.
• Deliver oral and written presentations to management in support of approval for execution and funding of development projects.

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