Senior Verification Engineer

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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! 

We are looking for a talented and dedicated Senior Verification Engineer to join our team focused on developing innovative medical devices that incorporate wearable technology and Software as a Medical Device (SaMD) subsystems. As a Senior Verification Engineer, you will play a crucial role in ensuring the safety, efficacy, and quality of our products by developing and executing comprehensive verification and validation activities.

What you will be doing

• Verification Planning:
• Develop comprehensive verification plans and test protocols based on system requirements, design specifications, and risk assessments.
• Define test cases, test methods, and acceptance criteria for various levels of testing (unit, integration, system).
• Ensure traceability between test cases and requirements.




• Test Execution and Analysis:
• Execute test protocols on medical device hardware, firmware, and software components.
• Perform functional testing, performance testing, usability testing, and compliance testing.
• Analyze test results, identify discrepancies, and document findings in clear and concise reports.




• Test Automation:
• Develop automated test scripts and frameworks to improve efficiency and repeatability of testing.
• Utilize scripting languages (e.g., Python) and test automation tools to automate test execution and data analysis.




• Documentation and Reporting:
• Generate comprehensive test reports documenting test procedures, results, and conclusions.
• Maintain detailed records of verification activities and contribute to regulatory submissions.
• Contribute to 510k and other regulatory filings.




• Collaboration:
• Collaborate closely with development teams (hardware, firmware, software) to ensure testability of designs and to resolve identified issues.
• Work with cross-functional teams (quality, regulatory, clinical) to ensure compliance with relevant standards and regulations.

What you need

• Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
• 3+ years of experience in verification and validation of medical devices, preferably with experience in wearable technology and/or SaMD.
• Strong understanding of medical device regulations and standards (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820).
• Experience with various verification methodologies and techniques.
• Proficiency in scripting languages (e.g., Python) and test automation tools.
• Familiarity with test management tools and defect tracking systems.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and as part of a team.

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.