Senior R&D Project Manager

iRhythm•San Francisco, CA

1d•Hybrid

About The Position

iRhythm Technologies, Inc. seeks a Senior R&D Project Manager (San Francisco, CA) to 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. Local telecommuting permitted up to 4 days per week. 10% domestic travel and 3% international travel required.

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.

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.