Senior R&D Project Manager (Medical Devices)

Location: San Francisco, CA, United States; fully on-site with local telecommuting permitted up to 4 days per week. Requires 10% domestic travel for internal meetings, training, conferences, audits, planning sessions, and other business activities.

Salary: $212,000–$254,000 per year

Company

hirify.global develops medical device products and clinical software solutions.

What you will do

• Lead and manage projects for the design and development of clinical software solutions for hirify.global products and services.
• Lead cross-functional teams and incorporate clinical, regulatory, compliance, budget, scope, and business requirements into delivery plans.
• Develop technical timelines, prioritize workstreams, maintain program roadmaps, and identify and resolve project roadblocks.
• Coordinate production releases and health monitoring activities while driving tactical project decisions.
• Support regulatory affairs with risk analysis, cybersecurity documentation, clinical data, software validation and verification, and algorithm performance testing.
• Oversee medical device and cybersecurity risk management, Agile and Scrum delivery, and maintenance of the product Design History File.

Requirements

• Master’s degree in Electrical Engineering, Biomedical Engineering, or a related field.
• At least 5 years of experience managing software development projects within medical device applications.
• Experience with technical project management, Agile methodologies, and large cross-functional teams.
• Knowledge of IEC 62304, IEC 62366, IEC 60601, ISO 14971, ISO 13485, and 21 CFR Part 820.
• Experience managing 510(k) submissions and other FDA regulatory submissions.
• Practical knowledge of US and international regulations, including FDA, EU MDR, PMDA, and UKCA for Software as a Medical Device.
• Experience with Smartsheet, Jira, Confluence, Jama, and Aha! for project, requirements, and product portfolio management.
• Experience supporting regulatory documentation covering risk analysis, cybersecurity, clinical data, software validation and verification, and algorithm performance testing.

Culture & Benefits

• Full-time employee position.
• Local telecommuting is permitted up to 4 days per week despite the fully on-site workplace classification.
• 10% domestic travel is required.
• Eligible for the employee referral program.