Senior R&D Project Manager at iRhythm Technologies

San Francisco, California, United States

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$185,994 – $246,000Compensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare TechnologyIndustries

Requirements

Master’s degree in Electrical Engineering, Biomedical Engineering or related field
5 years of experience managing software development projects within medical device applications
Experience with Technical Project management and Agile methodologies
Experience managing projects involving large cross-functional teams
Experience with standards and guidelines such as IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485 and 21 CFR Part 820
Experience 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)
Experience with software platforms including Smartsheet for project management, the Atlassian Toolset (Jira and Confluence), Jama for requirements management, and Aha! for product portfolio management
Experience 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

Responsibilities

Lead and manage 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
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 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
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

Skills

Agile Methodologies

Scrum

Medical Device Software

Regulatory Compliance

Cybersecurity

Risk Management

Design History File

Software Validation

Software Verification

Project Management

Roadmapping

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees