Johnson & Johnson

Staff Clinical Engineer, Interventional Oncology

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Cincinnati • Massachusetts • New Jersey • United States

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Salary

💰 $109,000 - $174,800 per year

Job Level

Lead

About the role

  • 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.

Requirements

  • 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.
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.
  • 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 period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial documentationrisk identificationusability studiesexperiment developmentcustomer requirements developmentinstruction for use developmentmedical device developmentdrug device combination product developmentdata collectiondata analysis
Soft Skills
teamworkcollaborationproblem-solvingcommunicationpresentation skillsleadershipstrategic thinkingrelationship buildingprioritizationadaptability