The Role
As a Senior Verification Engineer, you will develop test plans, execute verification protocols, and ensure compliance for medical devices.
Summary Generated by Built In
The future of healthcare is here. Join us to shape the future of healthcare for patients and clinicians. BioIntelliSense is helping to decode human physiology and pioneer a new standard of proactive monitoring to improve healthcare outcomes and save lives.
Our 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 our physiologic intelligence and 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.
We’re a remote-first, lean start-up environment and our global BioTeam colleagues are growth-oriented, collaborative and passionate about our mission and the future of BioIntelliSense. We thrive in a fast-paced environment and embrace challenges as opportunities to shape the future, together.
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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.
Company Culture and Benefits
Our Workplace Culture:
We’re a dynamic remote-first environment, with offices in Golden, CO and Redwood City, CA and a talented, motivated team of colleagues globally. We’re passionate about BioIntelliSense and are motivated by our shared mission. We’re a collaborative and welcoming team who thrive in the fast-paced start-up environment and are eager to advance an excellent workplace together.
As One BioTeam, we set a high bar for ourselves and are focused on scaling our solutions and outperforming expectations.
Comprehensive Benefits Package:
· Robust Medical, Dental and Vision Plans
· STD, LTD, Insurance Plans
· HSA and Flexible Spending Accounts
· Safe Harbor 401(k) Plan with 3% Employer Contribution with immediate vesting
· FlexVTO (flexible vacation plans), Sick Leave, 11 Company Holidays
· Home Office Benefits Stipend
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.
Top Skills
Python
Test Automation Tools
Test Management Tools
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The Company
What We Do
BioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM).
Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics, and symptomatic events through an effortless patient experience. The FDA-cleared, medical-grade BioButton® wearable device makes remote monitoring and early detection simple. Through the platform’s advanced analytics, clinicians have access to high-resolution patient trending and reporting to enable medical-grade remote care from in-hospital to home.
Learn how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services or visit our website at BioIntelliSense.com.
