Hybrid Senior Principal Engineer, Combination Products – Interventional Oncology

at OneTrust

• Job title: Senior Principal Engineer, Combination Products – Interventional Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $137,000 - $235,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Senior Principal Engineer developing combination products for Interventional Oncology at Johnson & Johnson. Collaborates with cross-functional teams to lead product development and execution.

Responsibilities

• 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.

Requirements

• Bachelor’s degree in engineering is required.
• A minimum of 10 years of medical device industry or related experience is required (8 years with advanced degree).
• Expert knowledge of drug-device combination product development is required.
• Combination product development experience from discovery through clinical trials is required, with commercialization/post-launch experience preferred.
• A proven track record of leading drug-device combination product development projects with multifunctional teams is required.
• Strong problem-solving skills for developing creative solutions and meeting project objectives is required.
• Demonstrated negotiation and conflict resolution skills, including the ability to influence without clear reporting authority is required.
• Strong project management, planning, and tracking skills are required.
• Demonstrated experience with external development and manufacturing partners is required.
• Experience preparing product development contributions for combination product regulatory filings for early and late stage clinical trials is required.
• Ability to develop and communicate project plans, including scenario and risk analyses, to external partners, senior leaders and technical teams is required.
• Ability to travel domestically and/or internationally up to 20% of the time is required.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• vacation –120 hours per calendar year
• sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• holiday pay, including Floating Holidays –13 days per calendar year
• work, personal and family time - up to 40 hours per calendar year
• parental leave – 480 hours within one year of the birth/adoption/foster care of a child
• condolence leave – 30 days for an immediate family member: 5 days for an extended family member
• caregiver leave – 10 days
• volunteer leave – 4 days
• military spouse time-off – 80 hours