Senior Principal Engineer, Combination Products, Interventional Oncology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ;br>
Job Function:
R&D Product Development

Job Sub Function:
Multi-Family R&D Product Development

Job Category:
Scientific/Technology

All Job Posting Locations:
Boston, Massachusetts, United States of America, Cambridge, Massachusetts, United States of America

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at ;br>
The Senior Principal Engineer will be responsible for supporting and leading combination product development efforts for Interventional Oncology (INTO) in support of priority drug assets for clinical trials and eventual commercialization. This individual will be responsible for execution of device related projects for the INTO portfolio, especially those identified as device constituents of drug-device combination products.

Responsibilities

The Senior Principal Engineer will:

• 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

Qualifications and 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.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:
Entrepreneurship, Mentorship, Product Development, Product Development Lifecycle, Product Strategies, Quality Assurance (QA), Research and Development, Research Documents, Research Ethics, Researching, Safety-Oriented, SAP Product Lifecycle Management, Science, Technology, Engineering, and Math (STEM) Application, Tactical Planning, Technical Credibility, Versatility

The anticipated base pay range for this position is :
$137,000 - $235,750

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: 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 Additional information can be found through the link below.