Staff Clinical Engineer, 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 ;br>
Johnson & Johnson Innovative Medicine is currently searching for the best talent for a Staff Clinical Engineer. This is an 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.

INTO's Clinical Engineers are professionals who bridge the gap between healthcare providers and medical technology development. They demonstrate their understanding of clinical workflows, human anatomy, human-centric design, and medical standards to design, develop, and maintain safe and effective intratumoral procedures and devices. By collaborating with physicians, as well as teams from R&D, clinical operations, quality, regulatory, and marketing, the Clinical Engineering team at J&J aim to develop solutions that meet and surpass user expectations. We are committed to enhancing the performance, safety, and efficacy of our products and procedures and strive to positively impact the lives of patients and healthcare providers.

As a Clinical Engineer, you will lead the development of clinical procedures that support clinical trials critical to the success of INTO's cross-sector Development Teams. You will guide the team in clinical procedures, working closely with clinical leads and principal investigators to design clinical trial protocols and procedural documentation. Additionally, you will identify optimal intratumoral procedure flow, unmet needs, and risks and assess technologies for their ability to mitigate those risks or meet those needs.

Key Responsibilities:

• Serve as a liaison between external healthcare providers and internal Development Teams, representing the HCP/user and providing domain expertise.
• Lead the development of intratumoral therapy procedures and supporting documents/manuals for clinical trials, focusing on managing risk through appropriate medical technology and techniques.
• Identify critical tasks that ensure safety and efficacy and facilitate their successful implementation in clinical trial investigations.
• Development of procedure/devices sections of clinical documentation such as study protocols, regulatory submissions, and site requirements.
• Collaborate with SMEs to establish tumor and anatomical models and experimental techniques to evaluate clinical performance, risks, and technologies.
• Lead the development and tracking of procedure endpoints within clinical trials, including development of data collection, analysis plans, and interpretation of procedural data.
• Identify, document, and translate clinical trial insights, unmet needs, and market feedback into opportunity statements, user requirements, and design solutions.
• Provide suggestions and recommendations to leadership on new opportunities, strategies, and tactics.
• Deliver oral and written presentations to management to support approval, funding, and execution of new initiatives.
• Attend scientific conferences and engage healthcare providers to deepen understanding of cancer patient care, emerging research, regulations, and new technologies.

Qualifications

• A Bachelor's degree in a technical field, with a strong understanding of biology is required. An advanced degree (MS, PhD, MBA) is preferred.
• Five or more years of professional experience in the healthcare, pharmaceutical and/or medical device industries with at least three years focused on product development within healthcare, pharmaceutical and/or medical device industries is required.
• Experience with at least four of the following is required, with a proven understanding of the remaining highly preferred:
  
  • Human factors processes and usability studies.
  • Use related risk identification and mitigation (e.g., uFMEA/aFMEA/URRA development).
  • Facilitating physician interaction, voice of customer, and/or contextual inquiry/ethnography studies.
  • Experiment development (designing, protocol, and report writing).
  • Customer/User requirements development.
  • Instruction for use development.
• Consistent track record of teamwork, collaboration, inclusion, and developing strong business relationships with internal teams and outside partners is required.
• Prioritizing tasks, leading several projects at a time, and working efficiently by eliminating/overcoming low-priority tasks or non-value-added activities are required.
• Strong problem-solving skills for developing creative solutions and meeting project objectives are required.
• The ability to present and communicate complex information, user insights, and scenario and risk analyses to external partners, senior leaders, and technical teams is required.
• Experience as an industry representative in an operating room environment is preferred.
• Experience working within the head and neck (Ear, nose, and throat), and/or lung/thoracic anatomical spaces is preferred.
• Medical device development experience, preferably late-stage development / working with design controls is preferred.
• Drug device combination product development experience is preferred.
• Experience working on clinical trials is preferred.
• Experience working with and influencing collaborators is preferred.
• Experience with domestic and international collaboration is preferred.
• Ability to travel domestically and/or internationally 20%, with some periods up to 40% 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 :
$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

Additional information can be found through the link below.

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