Senior Development Engineer, Combination Products, Interventional Oncology (INTO)

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development Job Sub Function:

Biomedical Engineering Job Category:

Scientific/Technology All Job Posting Locations:

Cambridge, Massachusetts, United States of America, Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, 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 https:

//www.jnj.com/innovative-medicine Johnson & Johnson Innovative Medicine is currently searching for the best talent for a Senior Development Engineer. This is a hybrid office-based role ( three days onsite) at any of the locations listed within the job posting. The Interventional Oncology (INTO) group, a cross-sector initiative at J&J, brings together the pharmaceutical and medical device expertise with the aim to meaningfully alter the course of cancer and improve survival. We conduct sophisticated clinical trials that involve the development of novel procedures and unique routes of administration for investigational cancer therapies. The Senior Development Engineer will be responsible for supporting combination product development efforts for 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 constituents of drug-device combination products. The Senior Development Engineer will collaborate with internal business partners to help shape, develop, and execute projects as well as leverage external partnerships to drive growth of the business.

Responsibilities:

Lead technical product design & development of devices and combination products through clinical trial readiness, including identification of specifications, requirements management, risk management, testing and evaluation, and generating evidence to support regulatory submissions Guide external partnerships to deliver collaborative outcomes aligned with program objectives, including partner identification and scoping, establishing clear communication pathways, and overseeing deliverables. Engage appropriate team members, including internal subject matter experts, and external academic and industry partners, to address technical challenges and risks Develop and update design documentation including, engineering drawings, test protocols, reports, and engineering rationales to support both quality and regulatory documentation under design control processes Maintain strong connections with J&J colleagues across medical devices and pharmaceutical sectors as well as J&J Legal, Finance, Regulatory, Clinical, Quality and other functional groups to support, review, and execute product development projects Build external relationships via trade shows, conferences, networking, and other new sources of information, intelligence, and insights Build knowledge of targeted disease states (e.g., head & neck cancer, non-small cell lung cancer, and other solid organs), standards of care, and procedural approaches through direct observation and primary and secondary research

Qualifications:

A Bachelor's degree in engineering is required Five or more years of professional experience in the medical device industry with at least three years focused on drug-led combination products is required. Experience in new product development & product design following design controls is required (full product development lifecycle experience highly preferred) Combination product development experience from discovery through clinical trials is required, with commercialization/post-launch experience preferred. Demonstrated track record of teamwork, collaboration, inclusion, and developing strong business relationships with multi-functional teams is required Experience leading through influence and working in a highly matrixed environment is preferred Experience with domestic and international multi-site collaboration is preferred 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. #

LI-Hybrid Required Skills:

Preferred Skills:

Bioinformatics, Biological Engineering, Biostatistics, Coaching, Critical Thinking, Design of Experiments (DOE), Healthcare Trends, Industry Analysis, Innovation, Medicines and Device Development and Regulation, Product Development, Relationship Building, Research and Development, Researching, SAP Product Lifecycle Management, Standard Scientific Processes and Procedures, Technologically Savvy The anticipated base pay range for this position is : $109,000.00

• $174,800.

00 Additional Description for

Pay Transparency:

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 Colorado
• 48 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 Bereavement Leave
• 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave
• 80 hours in a 52-week rolling period10 days Volunteer Leave
• 32 hours per calendar year Military Spouse Time-Off
• 80 hours per calendar year For additional general information on Company benefits, please go to:
• https://www.

careers.jnj.com/employee-benefits