Systems Engineer (Medical Devices)

TL;DR

Systems Engineer (Medical Devices): Developing and optimizing EEG device systems for precision brain health diagnostics with an accent on system requirements, verification, and risk management. Focus on integrating hardware, firmware, and software to ensure product reliability and regulatory compliance.

Location: Hybrid role based in Boston, MA

Salary: $120,000 – $140,000

Company

hirify.global is transforming precision medicine for the brain through a leading at-home EEG platform for clinical development and diagnostics.

What you will do

• Develop new and modified EEG device systems in accordance with QMS and Systems Engineering best practices.
• Elicit, analyze, and document system and sub-system requirements, ensuring full coherence and traceability throughout the product lifecycle.
• Implement verification and validation (V&V) processes, developing and executing test plans to assess performance and reliability.
• Lead risk management activities, including hazard analysis (dFMEA and FMEA) and mitigation strategies.
• Collaborate with Product Management, Algorithm, and Platform teams to ensure smooth sub-system integration.
• Support the transition from development to production and lead root cause analysis of issues at contract manufacturers.

Requirements

• BS in engineering (5+ years professional experience) or MS in engineering (3+ years professional experience).
• Experience leading cross-functional technical efforts across hardware, software, firmware, and operations.
• Proven track record in defining system architectures and detailed technical specifications for multidisciplinary electromechanical systems.
• Expertise in requirements traceability, risk analysis, and V&V throughout the product lifecycle.
• Must be based in Boston, MA for this hybrid position.
• Strong written and verbal communication skills for technical and non-technical stakeholders.

Nice to have

• Experience developing medical devices or other regulated, safety-critical products.
• Familiarity with medical device design controls and applicable regulatory standards.
• Experience with Git, JIRA, GitHub, and OpenBOM.

Culture & Benefits

• Total compensation package including base salary, equity, and PTO.
• Robust asynchronous work practices to support a high-quality hybrid experience.
• Culture driven by curiosity, simplicity, composability, and deep empathy for users and patients.
• Diverse team environment focused on high-impact scientific contributions.