7 дней назад
Principal R&D Engineer (MedTech)
117 000 - 201 250$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal R&D Engineer (MedTech): Leading catheter development from concept through commercialization, including prototype creation, design validation, technology transfer, and regulatory documentation with an accent on electrophysiology, electromagnetically navigated devices, flexible materials, and miniaturized electronics. Focus on architecting pre-clinical prototypes, de-risking designs, validating manufacturability, and mentoring engineers across multidisciplinary development programs.
Location: Irvine, California, United States; on-site five days a week. Up to 15% domestic and international travel may be required.
Salary: $117,000–$201,250 per year
Company
Johnson & Johnson MedTech develops healthcare solutions and medical devices, including technologies for cardiovascular care, electrophysiology, stroke, and heart recovery.
What you will do
- Lead electrophysiology catheter projects from concept through commercialization, aligning technical decisions with clinical needs and regulatory pathways.
- Architect prototypes, tools, and fixtures for pre-clinical testing and implement design validation protocols.
- De-risk designs and support development, manufacturing, process characterization, risk assessment, and early process validation.
- Prepare technical documentation, design controls, validation records, and materials supporting regulatory submissions and first-in-human activities.
- Collaborate with internal and external research partners on technology transfer and knowledge transfer.
- Mentor junior engineers, present project findings to senior management, and contribute to process improvement.
Requirements
- Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or a related technical discipline; a relevant master’s degree is preferred.
- At least 8 years of experience in medical device R&D, including prototyping, validation, and support for early clinical use.
- Expertise in electromagnetically navigated devices, advanced catheter materials, miniaturization, advanced manufacturing, design validation, and process development.
- Proficiency with AutoCAD and SolidWorks; familiarity with statistical software such as Minitab.
- Knowledge of regulatory compliance, manufacturing technologies, problem-solving, analytical reasoning, and project economics.
- Strong English communication skills and ability to work on-site in Irvine, California five days per week.
Nice to have
- Master’s degree focused on medical device development or materials science.
- Experience with flexible electronics, advanced materials, DTV/DTQ, or electromagnetically navigated devices.
- Familiarity with Model-Based Systems Engineering, SAP Product Lifecycle Management, scripting languages, or software quality assurance.
Culture & Benefits
- Work in a fast-paced R&D environment focused on rapid prototyping, iterative testing, scientific excellence, and patient impact.
- Collaborate with multidisciplinary teams and external research partners.
- Eligible employees receive vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, and volunteer leave.
- Inclusive work environment with accommodation support during the interview process.
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