Senior Technical Project Manager - Firmware Development

October 1

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BioIntelliSense, Inc

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💰 $45M Series B on 2021-07

Description

• Lead and manage firmware development projects from initiation through delivery, ensuring adherence to timelines, budgets, and quality standards. • Implement and promote agile project management practices, facilitating sprint planning, daily stand-ups, and retrospectives to enhance team productivity and collaboration. • Work closely with engineering, quality assurance, regulatory affairs, and product management teams to define project scope, requirements, and deliverables. • Ensure all firmware development processes comply with 21 CFR Part 820 and other relevant regulatory standards, including documentation and validation requirements. • Identify potential project risks and develop mitigation strategies to minimize impact on project timelines and deliverables. • Provide regular updates to stakeholders on project status, issues, and milestones, fostering transparency and accountability. • Guide and mentor junior project managers and team members, promoting a culture of continuous improvement and professional development. • Continuously evaluate and refine project management processes to enhance efficiency and effectiveness within the firmware development lifecycle.

Requirements

• 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 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.