Senior R&D Project Manager

TL;DR

Senior R&D Project Manager (Medical Devices): Lead cross-functional teams to design and develop clinical software solutions for cardiac health products with an accent on regulatory compliance, risk management, and Agile methodologies. Focus on preparing FDA submissions, overseeing medical device cybersecurity, and maintaining Design History Files under standards like IEC 62304 and ISO 14971.

Location: Hybrid in San Francisco, CA (local telecommuting up to 4 days per week, 10% domestic and 3% international travel required)

Salary: $164,714 to $246,000 per year

Company

hirify.global Technologies develops wearable devices and software for cardiac arrhythmia detection and diagnosis.

What you will do

• Lead cross-functional teams to incorporate clinical needs, regulatory, and compliance requirements into software design and development.
• Oversee production release, health monitoring, medical device risk management, and cybersecurity activities.
• Guide Agile and Scrum frameworks, build program roadmaps, timelines, and prioritize workstreams.
• Maintain product Design History Files (DHF) per compliance standards.
• Support regulatory affairs with documentation for submissions including risk analysis, cybersecurity, validation, and algorithm testing.
• Facilitate stakeholder communication, identify roadblocks, and drive tactical decisions.

Requirements

• Master’s degree in Electrical Engineering, Biomedical Engineering or related field and 5 years managing software development projects in medical devices.
• Experience with technical project management, Agile methodologies, and large cross-functional teams.
• Knowledge of standards: IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485, 21 CFR Part 820.
• Managing 510(k) and FDA regulatory submissions; US and international regulations (FDA, EU MDR, PMDA, UKCA) for SaMD.
• Tools: Smartsheet, Atlassian (Jira, Confluence), Jama, Aha!.

Culture & Benefits

• Growing organization with opportunities for skill development and career advancement.
• Impactful work in cardiac health, innovative thinking, and global patient reach.
• Hybrid work with local telecommuting, employee referral program.
• Purpose-driven culture focused on boundary-pushing healthcare solutions.