Senior Development Engineer, Combination Products, Interventional Oncology (INTO)
About The Position
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.
Requirements
- 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
- Ability to travel domestically and/or internationally up to 20% of the time is required
Nice To Haves
- Experience leading through influence and working in a highly matrixed environment is preferred
- Experience with domestic and international multi-site collaboration is preferred
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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
