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3 дня назад

Senior Clinical Engineer (MedTech)

109 000 - 174 800$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Senior Clinical Engineer (MedTech): Designing and validating clinical instruments for a table-integrated robotic surgical system with an accent on user needs, clinical requirements, risk assessment, and device performance. Focus on developing pre-clinical models, conducting FDA-compliant design validation studies, collaborating with physicians and engineering teams, and supporting robotic surgery product launch activities.

Location: Cincinnati, Ohio, United States of America

Salary: $109,000–$174,800 per year

Company

Johnson & Johnson MedTech develops innovative, minimally invasive, and personalized healthcare solutions, including robotic surgical systems.

What you will do

  • Collaborate with clinical, engineering, product management, human factors, regulatory, and professional education teams to develop and validate new medical devices.
  • Partner with physicians and clinical users to gather feedback, identify unmet needs, and characterize device performance.
  • Translate customer and clinical needs into engineering requirements, design inputs, and product workflows.
  • Develop bench models, metrics, clinical risk assessments, and mitigations for prototype evaluation and patient safety.
  • Create plans and protocols, conduct formal design validation testing, and report results in accordance with FDA requirements.
  • Support pre-clinical studies, customer training materials, user manuals, labeling, and initial product launch cases.

Requirements

  • Bachelor’s degree in engineering, such as biomedical or mechanical engineering, with at least 5 years of related medical device industry experience; equivalent paths include a master’s degree plus 4 years or a PhD plus 2 years.
  • Experience collaborating with physicians, gathering clinical performance feedback, and identifying unmet clinical needs.
  • Experience designing and conducting pre-clinical engineering studies focused on product performance and safety.
  • Experience with clinical risk and harm analysis, design validation strategy, protocol development, and testing.
  • Ability to construct customer and engineering design requirements and make recommendations from varied technical and clinical inputs.
  • Strong communication and cross-functional collaboration skills.

Nice to have

  • Master’s degree, PhD, or MD.
  • Knowledge of laparoscopic procedures, operating room workflows, and surgical robotics.
  • Experience with device or instrument design, statistical methods, MATLAB, Python, and big data.
  • Knowledge of FDA regulations, medical device standards, and IEC and ISO standards.
  • Experience leading complex projects from inception to completion; willingness to travel up to 15% domestically and internationally.

Culture & Benefits

  • Inclusive work environment that values diversity, individual contributions, autonomy, and collaboration.
  • Medical, dental, vision, life insurance, disability, business accident, and group legal insurance.
  • Pension and 401(k) savings plans, plus eligibility for a long-term incentive program.
  • Paid vacation, sick time, holidays, parental leave, caregiver leave, volunteer leave, and other time-off benefits.

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