Principal Systems Engineer - Medical Devices

October 5

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BioIntelliSense, Inc

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

☁️ SaaS

💰 $45M Series B on 2021-07

Description

• Early Detection Made Simple™ • Denver, CO based BioIntelliSense, Inc., founded in 2018, is an award-winning continuous health monitoring and clinical intelligence company. • The FDA-cleared and award-winning BioButton® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system create a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. • Join the BioTeam today and create a new standard of continuous care that delivers clinical value, economic benefits and operational efficiencies for providers, patients and caregivers globally! • The Principal Systems Engineer is a pivotal leadership role responsible for driving the development and integration of complex, end-to-end medical device systems. • You will oversee the entire ecosystem, encompassing wearable devices and sensors, gateways, cloud infrastructure, mobile applications, dashboards, software algorithms, and data engineering pipelines.

Requirements

• Bachelor's degree (Master's preferred) in Systems Engineering, Software Engineering, Biomedical Engineering, Computer Science / Engineering, Electrical Engineering, or a related field. • 10+ years of experience in systems engineering, with a significant focus on medical devices or other complex, end-to-end systems involving hardware and software integration. • Strong understanding of cloud and mobile technical domain including architecture, security, scalability and performance SLA. • Demonstrated success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry. • Proven expertise in systems modeling, requirements management, risk analysis, cybersecurity risk assessments, and verification/validation across hardware and software components. • Strong understanding of medical device regulations, quality systems, cybersecurity frameworks, and data privacy regulations (e.g., HIPAA). • Broad technical knowledge encompassing hardware (sensors, embedded systems), software (mobile apps, cloud applications, algorithms), and data engineering. • Understanding of human physiology and state of the art medical device technology. • Demonstrated ability to work across disciplines to build consensus and drive complex systems to completion. • Experience converting complex technical, business and regulatory requirements or challenges into clear and actionable strategies. • Thorough understanding of medical device risk management and regulations. • Experience in requirements definition and flow down, management, validation, and verification practices. • Excellent communication, self-management, planning and organization, attention to detail, and ability to motivate and engage team members. • Able to work well within a high growth, collaborative team environment and adapt quickly to change.

Benefits

• Medical/Dental/Vision/Life • Disability (STD & LTD) • 401(k) auto contribution program • 11 paid holidays per year • Generous paid time off • Weekly lunch perk