Principal Systems Engineer - Medical Devices (End-to-End Systems)

Early Detection Made Simple™

Denver, CO based BioIntelliSense, Inc., founded in 2018, is an award-winning continuous health monitoring and clinical intelligence company.  Our market acceleration and expansion are driven by world-class executive management and a dedicated team of engineers, data scientists, commercial and operational professionals, which collectively harness decades of expertise in virtual care innovations, wearable sensor development, remote connectivity solutions and successful program execution. With these distinctive capabilities and proprietary continuous Remote Patient Monitoring (cRPM) technologies, BioIntelliSense is uniquely poised to transform care delivery from in-hospital to home.

The FDA-cleared and award-winning BioButton® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through the platform’s AI-driven analytics, clinicians have access to high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care.

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! 

About The Role

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. You will apply systems engineering principles throughout the entire product lifecycle, from concept and design to verification, validation, and product launch, with a strong focus on cybersecurity, requirement management, and robust verification and validation processes. This role requires a deep understanding of medical device regulations, cybersecurity best practices, a broad technical background spanning hardware, software, mobile and cloud technologies. Excellent project management skills.

• Systems Engineering Leadership (End-to-End): 
• Lead the definition and capture of system architecture, requirements, and specifications for end-to-end medical device systems, ensuring seamless integration and interoperability between wearable devices, gateways, cloud infrastructure, mobile applications, and dashboards. 
• Develop comprehensive system models, risk analyses, and mitigation strategies, addressing the unique challenges of each component in the end-to-end system. 
• Technical Expertise (Full Stack): 
• Provide expert guidance on technical challenges and design trade-offs across the end-to-end software system software, encompassing mobile apps, dashboards, algorithmsand cloud infrastructure. 
• Evaluate and select appropriate technologies and components for each element of the end-to-end system, considering factors like power consumption, connectivity, security, and data throughput. 
• Conduct in-depth analysis of system performance, reliability, and data integrity across the entire data pipeline, from sensor data collection to cloud storage and processing. 
• Cybersecurity, Requirement Management, and V&V: 
• Implement end-to-end cybersecurity controls and measures to protect patient data and ensure the confidentiality, integrity, and availability of medical device systems. 
• Define, document, and manage system requirements across all components of the end-to-end system, ensuring traceability and alignment with regulatory standards. 
• Oversee comprehensive test plans and protocols to verify and validate system performance, safety, and cybersecurity across the entire end-to-end ecosystem. 
• Data Engineering and Algorithms: 
• Collaborate with data engineers and scientists to design and implement robust data pipelines for collecting, processing, and analyzing data from wearable devices and sensors. 

• Education: Bachelor's degree (Master's preferred) in Systems Engineering, Computer Engineering, or a related field. 
• Experience: 
• 10+ years of experience in systems engineering, with a significant focus on connected medical devices or other complex, end-to-end systems involving hardware and software integration. 
• 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. 
• Strong understanding of medical device regulations, quality systems, cybersecurity frameworks, and data privacy regulations (e.g., HIPAA). 
• Skills: 
• Broad technical knowledge encompassing hardware (sensors, embedded systems), software (mobile apps, cloud applications, algorithms), and data engineering. 
• 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, and experience with, 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. 

You'll be excited about this opportunity because you will:

- Join a fast-growing company and grow right along with us

- Work on challenging and interesting tech problems which reshape the future of healthcare

- Get the chance to work on cutting-edge technologies

- Make a large impact across the company through business deliverables and continuous innovation

- Opportunity to build solutions and organizations

Why You'll Love Working at BioIntelliSense

We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.

We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do.

We are learning - We're not afraid to dig in and uncover the truth, even when it's inconvenient. Everyone here is continually learning on the job.

We have great benefits - Medical/Dental/Vision/Life, disability (STD & LTD), 401(k) auto contribution program, 11 paid holidays per year, generous paid time off and a weekly lunch perk.

BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.