System Engineer
SANTA CLARA, CAPosted 25 days ago
Job summary
Job post source
This job is directly from Stealth Startup - Energy Based Therapeutic Medical Devices
Job overview
The System Engineer role involves developing advanced catheter-based medical devices integrating energy-based therapeutic systems, crucial for ensuring regulatory compliance and delivering innovative healthcare solutions.
Responsibilities and impact
The candidate will develop and execute test protocols, oversee compliance testing, troubleshoot electromechanical systems, analyze data using MATLAB or Python, collaborate with cross-functional teams for system integration, and support regulatory documentation and submissions.
Experience and skills
Requires a Bachelor's degree in Electrical or Biomedical Engineering or equivalent experience, with at least 5 years in medical device systems engineering, proficiency in MATLAB or Python, knowledge of IEC 60601-1 and 60601-1-2 testing, and familiarity with FDA, ISO 13485, and EU MDR standards; experience with energy-based therapeutic devices is preferred.
Career development
The role offers growth in a dynamic, mission-driven environment with opportunities to contribute to innovative medical device development and advance in a collaborative team.
Work environment and culture
The company promotes a collaborative and innovative culture focused on improving patient care in a dynamic and mission-driven environment.
Company information
The company is a stealth start-up focused on developing novel catheter-based technologies for treating Peripheral Artery Disease and Coronary Artery Disease using energy-based therapeutic medical devices.
Unique job features
The job involves working on cutting-edge catheter-based medical devices integrating energy-based therapies, with a focus on regulatory compliance and advanced system testing and validation.
Company overview
This stealth startup operates in the healthcare sector, focusing on the development of energy-based therapeutic medical devices designed to address unmet clinical needs. The company leverages advanced technologies such as ultrasound, radiofrequency, or laser energy to create innovative solutions for non-invasive or minimally invasive treatments. Revenue is typically generated through device sales, licensing agreements, and partnerships with hospitals or medical providers. While specific details remain confidential due to its stealth status, candidates should be aware that the company is likely in early-stage development, prioritizing intellectual property protection and regulatory strategy as it prepares for market entry. Understanding the competitive landscape in medical device innovation and the importance of clinical validation will be valuable for applicants.
How to land this job
Position your resume to emphasize your hands-on experience with electromechanical systems, especially those related to energy-based therapeutic devices like RF or pulsed-field ablation generators, to align with the core technology of this stealth startup.
Highlight your expertise in IEC 60601-1 and 60601-1-2 compliance testing, system troubleshooting, and custom test method development, as these are critical responsibilities outlined in the job description.
Apply through multiple channels including the Stealth Startup's official corporate career page and LinkedIn to maximize your chances of being noticed for this specialized role.
Connect with current employees in the systems engineering or R&D divisions on LinkedIn, using ice breakers such as asking about the challenges of integrating catheter-based systems with energy therapies or expressing genuine interest in their innovative approach to PAD and CAD treatment.
Optimize your resume for ATS by incorporating keywords from the job description such as 'electromechanical system development,' 'IEC 60601-1 compliance,' 'MATLAB,' 'Python,' 'system validation,' and 'medical device regulatory standards' to ensure it passes automated screening tools.
Consider using Jennie Johnson's Power Apply feature to automate tailored applications across multiple platforms, identify relevant LinkedIn contacts for networking, and customize your resume for ATS, freeing you to focus on interview preparation and skill enhancement.
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