Senior R&D Project Manager

iRhythm Holdings, Inc.; San Francisco (CA); Hybrid; USD 212,000 - 254,000; Full time

Benefits offered by this job

Employee referral program

Job summary

iRhythm Technologies, Inc. seeks a Senior R&D Project Manager to lead and manage software design and development for clinical solutions.

You will lead a cross-functional team, ensuring regulatory and cybersecurity requirements are reflected in the software lifecycle, and participate in production release and health monitoring activities. Develop technical timelines, prioritize workstreams, and keep stakeholders aligned on goals, timelines, and compliance.

Qualifications

• Master’s degree in Electrical or Biomedical Engineering or related field.
• 5+ years of software project management in medical device applications.
• Experience with IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485 and 21 CFR Part 820.
• Managing 510(k) submissions and regulatory submissions to FDA.
• US/intl regulations including FDA, EU MDR, PMDA, UKCA for SaMD.

Responsibilities

• Lead cross-functional teams to deliver clinical software solutions.
• Ensure regulatory and cybersecurity requirements are integrated into design and development.
• Develop timelines/roadmaps to meet program strategy, budget, scope and business needs.
• Coordinate stakeholders to align goals, timelines and compliance needs.
• Support regulatory submissions and DHF maintenance; guide risk management activities.

Skills

Technical project management

Agile methodologies

Cross-functional leadership

Regulatory compliance (SaMD)

FDA submissions (510(k))

Toolset: Smartsheet, Jira, Confluence,

Jama, Aha!

Education

Master's degree in Electrical/Biomedical Eng

Tools

Smartsheet

Jira

Confluence

Jama

Aha!

Job description

Position

Senior R&D Project Manager

Location

699 8th Street, Suite 600, San Francisco, CA 94103

Responsibilities

iRhythm Technologies, Inc. seeks a Senior R&D Project Manager to lead and manage projects aimed at the design and development of clinical software solutions for iRhythm products and services. Lead a cross-functional team to ensure that clinical needs are met by incorporating regulatory and compliance requirements into the software design and development process. Participate in production release/ health monitoring activities. Develop a technical project timeline to meet program strategy, budget, scope and business needs. Prioritize program workstreams, consistent with program strategy. Identify potential roadblocks early and lead the team to develop and implement counter measures. Facilitate and foster strong communication among stakeholders, ensuring all parties are aligned on the goals, timelines and compliance needs. Drive tactical decisions for projects. Support regulatory affairs to prepare necessary documentation such as risk analysis, cybersecurity documents, clinical data, software validation and verification, and algorithm performance testing for regulatory submissions. Oversee execution of medical device and cybersecurity risk management projects/activities. Guide and manage the usage of Agile Methodologies and Scrum frameworks to simplify program delivery. Establish and maintain the product Design History File (DHF) following compliance and regulatory standards. Work with product and engineering teams to build and maintain clear program roadmaps. Local telecommuting permitted up to 4 days per week. 10% domestic travel required to attend meetings for internal company meetings, training sessions, conferences, audits, planning sessions, or other business-related activities.

Salary Range

$212,000 to $254,000 per year

Job Requirements

Requires a Master’s degree in Electrical Engineering, Biomedical Engineering or related field and 5 years of experience managing software development projects within medical device applications. Must have experience with: Technical Project management and Agile methodologies; Managing projects involving large cross-functional teams; Standards and guidelines such as IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485 and 21 CFR Part 820; Managing 510(k) submission(s) and other regulatory submissions to the FDA; Practical knowledge of US and international regulations including FDA, EU MDR, PMDA, and UKCA for Software as a Medical Device (SaMD); Software platforms including Smartsheet for project management, the Atlassian Toolset (Jira and Confluence), Jama for requirements management, and Aha! for product portfolio management; and Supporting regulatory affairs to prepare necessary documentation such as risk analysis, cybersecurity documents, clinical data, software validation and verification, and algorithm performance testing for regulatory submissions. 10% domestic travel required to attend meetings for internal company meetings, training sessions, conferences, audits, planning sessions, or other business-related activities.

This Position Is Eligible for the Employee Referral Program

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. Together, we are reimagining the way cardiac arrhythmias are diagnosed. We need curious problem solvers like you. With opportunities remotely, at our office, in manufacturing, and in locations across the globe, this is your chance to meaningfully shape the future of cardiac health, our company, and your career. Driven By Purpose - Cardiac health touches the lives of people all around us. Providing life-changing healthcare solutions that impact patients around the world drives us to bring our best every single day. Growth Means Opportunity - We are growing rapidly. And with that growth comes a wealth of opportunities to learn and advance at iRhythm. The potential to deepen your impact, seek new opportunities, and advance your career is yours to pursue. Build the Future - We are a boundary-pushing organization that values innovative thinking and impacts healthcare at a global level. The expectation is to think big and build the future you see for iRhythm, our patients, and yourself.