3 дня назад
Senior Clinical Engineer (MedTech)
109 000 - 174 800$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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