Responsible for the full SW architecture of cloud connectivity focused around device data management and over the air updates
Leading a small group of software engineers to bring cloud connectivity and security to new medical devices
Collaborate with company cloud infrastructure, regulatory, quality, and deployment strategists
Ensure compliance with IEC 62304, FDA regulations, and various regulations required in a global deployment
Contribute to system risk analyses to ensure compliance with guidelines such as ISO 14971
Mentor and develop cloud and security skillset within the team

Requirements

Bachelor’s Degree in Computer Science or similar
Minimum of 10 years (prefer 15+ years) working as a Software Engineer with 3+ years in a software architect or principal engineer role
Proven design experience designing software for complex Class II or Class III medical systems
Experience working within a regulated industry, operating within a medical quality system, and a solid understanding of IEC 62304, ISO 14971, ISO 13485, and FDA QSRs
Experience defining a security architecture
Familiarity with safety classification of software items and software risk management
Experience with version control (e.g., Git), requirement management (e.g., DOORS, Jama), and issue tracking tools (e.g., Jira)
Strong written and verbal communication skills
Willingness to work on a small team in a fast-paced environment

Benefits

medical insurance
dental insurance
vision insurance
401(k) retirement plan
life insurance
long-term and short-term disability insurance
paid parking/public transportation
paid time off
paid sick and safe time

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

software architecturecloud connectivitydevice data managementover the air updatessecurity architecturesoftware designrisk managementversion controlrequirement managementissue tracking

Soft Skills

leadershipmentoringcollaborationcommunicationteamworkadaptabilityproblem-solvingorganizational skillsfast-paced environmentinterpersonal skills

Certifications

Bachelor’s Degree in Computer ScienceIEC 62304 certificationISO 14971 certificationISO 13485 certificationFDA QSR compliance training