Arenal Medical
Research & Development Engineer, Advanced Vascular Diagnostics (Baltimore)
Arenal Medical, Baltimore, Maryland, United States, 21276
Overview
Position Title:
Research & Development Engineer, Advanced Vascular Diagnostics (Baltimore) Location:
Baltimore, Maryland (100% On-site) Company:
Arenal Medical About Arenal Medical: A Mission to Redefine Cardiovascular Care Cardiovascular Disease (CVD) is the leading health challenge globally, and Peripheral Arterial Disease (PAD) represents a critical unmet need. Arenal Medical is developing a patented, multi-sensor ultrasound platform to enable fast, accurate PAD screening at the point of care. Our goal is to drive a new model of cardiovascular healthcare by democratizing access to diagnosis and enabling early treatment. We aim to support FDA 510(k) submissions and widely adopt a technology designed to reduce amputations and improve outcomes. The Opportunity: Build the Engine of a Healthcare Revolution This is more than an engineering role. You will be the primary technical owner of our next-generation diagnostic platform, taking ultrasound technology from benchtop experiments through prototyping, performance optimization, miniaturization, design for manufacturing, and toward a market-ready medical device that redefines cardiovascular disease detection. You will lead as the hands-on engineer responsible for the engine of our clinical and commercial success, contributing to a potential FDA 510(k) submission and enabling broad adoption of this life-saving technology. Key Responsibilities Lead Hands-On Prototyping & System Integration:
Design, build, and test complex electro-mechanical prototypes. Integrate hardware components, including a novel ultrasound sensor platform, EKG signal sources, and custom control units, to create a cohesive diagnostic system. Drive System Performance Optimization:
Lead hardware and software optimization to dramatically increase data sampling frequency and clinical fidelity for accurate diagnostics. Execute Rigorous Verification & Validation (V&V):
Develop and execute comprehensive V&V test protocols (bench, phantom studies) to characterize performance and ensure the device meets design specifications. Author test reports suitable for inclusion in a Design History File (DHF) for an FDA 510(k) submission. Own Design for Manufacturing (DFM) & Miniaturization:
Evolve the system from prototype to robust, cost-effective product. Collaborate with contract manufacturers to optimize for mass production. Conduct Data Acquisition & Analysis:
Perform hands-on experiments with biometric data (e.g., Pulse Wave Velocity) using scripting and analysis tools (e.g., MATLAB, Python, LabVIEW). Maintain Rigorous Documentation:
Ensure designs, tests, and results are documented to medical device quality standards (FDA QSR, ISO 13485).
Required Qualifications
Bachelor of Science in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a closely related field. A minimum of 35 years of hands-on experience in medical device R&D with a track record of contributing to successful projects. Experience designing, prototyping, and testing complex electro-mechanical systems, including analog and digital circuits. Proficiency with laboratory data acquisition systems and standard test equipment (e.g., oscilloscopes, function generators, logic analyzers). Direct experience with the medical device product development lifecycle, from concept through verification and validation. Strong analytical and problem-solving skills; able to work independently and drive projects in a dynamic startup environment. Excellent technical writing skills, including rigorous documentation practices (test protocols and reports).
Preferred Qualifications
Masters degree or PhD in a relevant engineering discipline. Direct experience with ultrasound technology, acoustic signal processing, or medical imaging systems. Experience in FDA-regulated environments (21 CFR 820) and understanding of ISO 13485, IEC 60601. Advanced proficiency in data analysis, signal processing, and test automation (MATLAB, Python, LabVIEW). Experience with Design for Manufacturing (DFM) and design transfer with contract manufacturers. Familiarity with schematic capture and PCB layout tools (e.g., Altium, Eagle, OrCAD).
Why Join Arenal Medical?
Make a Tangible Impact:
Your work will directly contribute to a device that saves lives by addressing a large unmet clinical need. High-Ownership Role:
Be the foundational hardware and systems engineer in a growing company with a path to technical leadership. Join a Mission-Driven Team:
Work with founders and colleagues dedicated to a more equitable standard of cardiovascular care.
Arenal Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Additional Details Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Engineering and Information Technology Industries:
Medical Equipment Manufacturing
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Position Title:
Research & Development Engineer, Advanced Vascular Diagnostics (Baltimore) Location:
Baltimore, Maryland (100% On-site) Company:
Arenal Medical About Arenal Medical: A Mission to Redefine Cardiovascular Care Cardiovascular Disease (CVD) is the leading health challenge globally, and Peripheral Arterial Disease (PAD) represents a critical unmet need. Arenal Medical is developing a patented, multi-sensor ultrasound platform to enable fast, accurate PAD screening at the point of care. Our goal is to drive a new model of cardiovascular healthcare by democratizing access to diagnosis and enabling early treatment. We aim to support FDA 510(k) submissions and widely adopt a technology designed to reduce amputations and improve outcomes. The Opportunity: Build the Engine of a Healthcare Revolution This is more than an engineering role. You will be the primary technical owner of our next-generation diagnostic platform, taking ultrasound technology from benchtop experiments through prototyping, performance optimization, miniaturization, design for manufacturing, and toward a market-ready medical device that redefines cardiovascular disease detection. You will lead as the hands-on engineer responsible for the engine of our clinical and commercial success, contributing to a potential FDA 510(k) submission and enabling broad adoption of this life-saving technology. Key Responsibilities Lead Hands-On Prototyping & System Integration:
Design, build, and test complex electro-mechanical prototypes. Integrate hardware components, including a novel ultrasound sensor platform, EKG signal sources, and custom control units, to create a cohesive diagnostic system. Drive System Performance Optimization:
Lead hardware and software optimization to dramatically increase data sampling frequency and clinical fidelity for accurate diagnostics. Execute Rigorous Verification & Validation (V&V):
Develop and execute comprehensive V&V test protocols (bench, phantom studies) to characterize performance and ensure the device meets design specifications. Author test reports suitable for inclusion in a Design History File (DHF) for an FDA 510(k) submission. Own Design for Manufacturing (DFM) & Miniaturization:
Evolve the system from prototype to robust, cost-effective product. Collaborate with contract manufacturers to optimize for mass production. Conduct Data Acquisition & Analysis:
Perform hands-on experiments with biometric data (e.g., Pulse Wave Velocity) using scripting and analysis tools (e.g., MATLAB, Python, LabVIEW). Maintain Rigorous Documentation:
Ensure designs, tests, and results are documented to medical device quality standards (FDA QSR, ISO 13485).
Required Qualifications
Bachelor of Science in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a closely related field. A minimum of 35 years of hands-on experience in medical device R&D with a track record of contributing to successful projects. Experience designing, prototyping, and testing complex electro-mechanical systems, including analog and digital circuits. Proficiency with laboratory data acquisition systems and standard test equipment (e.g., oscilloscopes, function generators, logic analyzers). Direct experience with the medical device product development lifecycle, from concept through verification and validation. Strong analytical and problem-solving skills; able to work independently and drive projects in a dynamic startup environment. Excellent technical writing skills, including rigorous documentation practices (test protocols and reports).
Preferred Qualifications
Masters degree or PhD in a relevant engineering discipline. Direct experience with ultrasound technology, acoustic signal processing, or medical imaging systems. Experience in FDA-regulated environments (21 CFR 820) and understanding of ISO 13485, IEC 60601. Advanced proficiency in data analysis, signal processing, and test automation (MATLAB, Python, LabVIEW). Experience with Design for Manufacturing (DFM) and design transfer with contract manufacturers. Familiarity with schematic capture and PCB layout tools (e.g., Altium, Eagle, OrCAD).
Why Join Arenal Medical?
Make a Tangible Impact:
Your work will directly contribute to a device that saves lives by addressing a large unmet clinical need. High-Ownership Role:
Be the foundational hardware and systems engineer in a growing company with a path to technical leadership. Join a Mission-Driven Team:
Work with founders and colleagues dedicated to a more equitable standard of cardiovascular care.
Arenal Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Additional Details Seniority level:
Mid-Senior level Employment type:
Full-time Job function:
Engineering and Information Technology Industries:
Medical Equipment Manufacturing
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