Senior R&D Project Manager
iRhythm Technologies, Inc.
Summary
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.
Job description
Responsibilities
- 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.
Requirements
- Master's degree in Electrical Engineering, Biomedical Engineering or related field
- 5 years of experience managing software development projects within medical device applications
- 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, Atlassian Toolset (Jira and Confluence), Jama, and Aha!
- Supporting regulatory affairs to prepare documentation such as risk analysis, cybersecurity documents, clinical data, software validation and verification, and algorithm performance testing
- 10% domestic travel required
Benefits
- Employee Referral Program
Company overview
iRhythm Technologies, Inc. is a leading digital healthcare company specializing in cardiac monitoring solutions. Founded in 2006 and publicly traded on NASDAQ under the ticker IRTC, the company has developed the innovative Zio platform, which combines wearable biosensors with cloud-based data analytics and proprietary algorithms to transform cardiac care. iRhythm's technology distills data from millions of heartbeats into clinically actionable information, enabling physicians to diagnose arrhythmias more quickly and efficiently than traditional methods. The company's flagship product, Zio by iRhythm, represents a significant advancement in ambulatory cardiac monitoring, offering long-term continuous monitoring that helps avoid multiple indeterminate tests and allows for appropriate medical intervention. With headquarters in San Francisco, California, iRhythm operates globally with a workforce of 1,001-5,000 employees dedicated to advancing digital health solutions. The company's mission focuses on creating trusted solutions that detect, predict, and prevent disease through a relentless focus on patient care, delivering better data, better insights, and better health outcomes for all.