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

⚕️ About BioIntelliSense:

BioIntelliSense, Inc., founded in 2018, is a Denver, CO-based, award-winning company specializing in continuous health monitoring and clinical intelligence. We're driven by a team of engineers, data scientists, and commercial professionals with extensive experience in virtual care, wearable sensors, and remote connectivity. Our FDA-cleared BioButton® wearables, BioHub™ gateways, BioMobile™ app, BioCloud™ data services, and BioDashboard™ system offer a comprehensive solution for reliable and scalable continuous monitoring. We're transforming care delivery from hospital to home.

🚀 About The Role:

This pivotal leadership role requires driving the development and integration of complex, end-to-end medical device systems. You'll oversee the entire ecosystem, from wearable devices and sensors to cloud infrastructure, mobile applications, and dashboards. You'll apply systems engineering principles throughout the product lifecycle, focusing on cybersecurity, requirement management, and robust verification and validation processes. A deep understanding of medical device regulations and cybersecurity best practices is essential, along with a broad technical background spanning hardware, software, mobile, and cloud technologies. Excellent project management skills are a must.

🎯 What You'll Be Doing:

• Systems Engineering Leadership (End-to-End): Lead the definition and capture of system architecture, requirements, and specifications. Ensure seamless integration and interoperability between all system components. Develop system models, risk analyses, and mitigation strategies.
• Technical Expertise (Full Stack): Provide expert guidance on technical challenges. Evaluate and select appropriate technologies and components. Conduct in-depth analysis of system performance, reliability, and data integrity.
• Cybersecurity, Requirement Management, and V&V: Implement end-to-end cybersecurity controls. Define, document, and manage system requirements. Oversee comprehensive test plans and protocols to verify and validate system performance, safety, and cybersecurity.
• Data Engineering and Algorithms: Collaborate with data engineers and scientists to design and implement robust data pipelines for collecting, processing, and analyzing data.

👨‍💻 What You Need:

• 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. Proven success in leading the development of end-to-end systems, ideally in the medical device or healthcare industry. 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, software, and data engineering. Ability to work across disciplines. Experience converting complex requirements into clear strategies. Thorough understanding of medical device risk management and regulations. Experience in requirements definition, management, validation, and verification practices. Excellent communication, self-management, planning, and organizational skills. Ability to motivate and engage team members. Adaptability to a high-growth, collaborative team environment.

💰 Salary: $140,000 - $150,000 a year (Total compensation based on experience and location)

🌎 Location: Remote (Must be located in the U.S.)

➕ Why BioIntelliSense?

• Join a fast-growing company.
• Work on challenging tech problems reshaping healthcare's future.
• Work with cutting-edge technologies.
• Make a large impact through business deliverables and innovation.
• Opportunity to build solutions and organizations.
• Excellent benefits: Medical/Dental/Vision/Life, disability (STD & LTD), 401(k) auto contribution, 11 paid holidays, generous PTO, and a weekly lunch perk.

➡️ Apply Now!