Staff Clinical Engineer, Interventional Oncology (INTO)

Johnson & Johnson Innovative Medicine • Cincinnati, OH

13d • $109,000 - $174,800 • Hybrid

About The Position

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.

Requirements

• A Bachelor’s degree in a technical field, with a strong understanding of biology is required.
• 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.
• Ability to travel domestically and/or internationally 20%, with some periods up to 40% of the time is required.

Nice To Haves

• An advanced degree (MS, PhD, MBA) is preferred.
• 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.

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.

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
• Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level