Systems Engineer II (Medtech)

TL;DR

Systems Engineer II (Medtech): Developing system-level solutions and requirements for mobile application features in diabetes care technology with an accent on globalized product design and requirements management. Focus on designing scalable solutions, managing inter-system interface specifications, and ensuring traceability between business needs and technical implementation.

Location: Hybrid (2-3 days per week in office in Del Mar, CA). Must be authorized to work in the U.S. (no sponsorship available).

Salary: $81,000 - $110,000 annually

Company

hirify.global creates innovative insulin delivery systems and advanced predictive algorithms to improve the lives of people with diabetes.

What you will do

• Develop system-level solutions and requirements for mobile application features.
• Create and own system/subsystem designs and inter-system interface specifications.
• Collaborate with software development, product management, cybersecurity, and QA teams.
• Provide system expertise for troubleshooting and failure analysis of on-market products.
• Contribute to the risk management process and derive necessary mitigation requirements.
• Ensure full traceability between user needs, business requirements, and system specifications.

Requirements

• Bachelor’s degree in System Engineering, Electrical Engineering, Computer Science, or Biomedical Engineering.
• 2+ years of experience as a Systems Engineer.
• 2+ years of experience in a regulated industry (Medical Device industry preferred).
• Proficiency in requirements management, design trade-offs, and failure mode analysis.
• Familiarity with ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30, HIPAA, or GDPR.
• Must be authorized to work for any employer in the U.S.

Culture & Benefits

• Comprehensive health care (medical, dental, vision) available from the first day.
• 401k plan with company match and Employee Stock Purchase plan.
• Generous time off: minimum 20 days PTO and 11 paid holidays per year.
• Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• Supportive environment focused on human-centered design and personal commitment to the cause.