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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 & 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 Bachelors 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 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 :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Senior IC