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Senior Technical Project Manager-Firmware Development (Contract)

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s degree in Engineering or related field, 7+ years of project management experience, Strong understanding of 21 CFR Part 820, Proven experience with agile methodologies, PMP or equivalent certification preferred.

Key responsabilities:

Lead and manage firmware development projects
Implement agile project management practices
Work closely with cross-functional teams
Ensure compliance with regulatory standards
Identify project risks and develop mitigation strategies

BioIntelliSense, Inc Medical Device SME https://biointellisense.com/

51 - 200 Employees

See more BioIntelliSense, Inc offers

Job description

We are seeking a highly skilled Senior Technical Project Manager with extensive experience in 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.

1 Year contract

What you'll do

Project Leadership: Lead and manage 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 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.