Description
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.
About the Role - This Is a 1-Year Contract, Must be located in the U.S.
We are seeking a highly skilled Senior Technical Project Manager with extensive experience in embedded device firmware development and a deep understanding of agile project management methodologies. The ideal candidate will have a strong background in the medical device industry, specifically in compliance with 21 CFR Part 820. This role will involve leading cross-functional teams to deliver high-quality firmware solutions for our innovative medical devices, ensuring that projects are completed on time, within scope, and aligned with regulatory standards.
What You'll Be Doing
- Project Leadership: Lead and manage embedded device firmware development projects from initiation through delivery, ensuring adherence to timelines, budgets, and quality standards.
- Agile Methodologies: Implement and promote agile project management practices, facilitating sprint planning, daily stand-ups, and retrospectives to enhance team productivity and collaboration.
- Cross-Functional Collaboration: Work closely with engineering, quality assurance, regulatory affairs, and product management teams to define project scope, requirements, and deliverables.
- Regulatory Compliance: Ensure all firmware development processes comply with 21 CFR Part 820 and other relevant regulatory standards, including documentation and validation requirements.
- Risk Management: Identify potential project risks and develop mitigation strategies to minimize impact on project timelines and deliverables.
- Stakeholder Communication: Provide regular updates to stakeholders on project status, issues, and milestones, fostering transparency and accountability.
- Mentorship: Guide and mentor junior project managers and team members, promoting a culture of continuous improvement and professional development.
- Process Improvement: Continuously evaluate and refine project management processes to enhance efficiency and effectiveness within the firmware development lifecycle.
What You Need
- Bachelor’s degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
- 7+ years of experience in project management, with a focus on embedded device firmware development for medical devices.
- Proven experience with agile project management methodologies (e.g., Scrum, Kanban).
- Strong understanding of 21 CFR Part 820 regulations and quality management systems.
- Excellent leadership, communication, and interpersonal skills, with the ability to motivate teams and manage stakeholder expectations.
- Proficient in project management tools (e.g., JIRA, Trello, MS Project).
- PMP or equivalent certification preferred.
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