Principal Systems Engineer (Medical Devices)

Location: Pittsburgh, PA, United States; onsite at the hirify.global Cardiac Management Solutions offices

Annual salary: $170,000–$190,000

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including cardiac management technologies such as LifeVest, HFMS, and TherOx.

What you will do

• Translate patient and stakeholder needs into system-level and detailed engineering requirements.
• Lead system architecture definition and collaborate with engineering teams to refine the architecture.
• Drive cross-functional review and approval of engineering requirements across R&D and non-R&D departments.
• Identify technical investigations addressing architectural uncertainties, requirement unknowns, and technical risks.
• Support test-case generation, engineering verification, reliability testing, FMECA analysis, and product risk management.
• Coordinate with engineering managers and technical program managers to identify resource needs.

Requirements

• Bachelor’s or master’s degree, or equivalent industry experience, in engineering or a related discipline.
• 10+ years of product development experience.
• Proven experience planning, directing, and conducting engineering research and development activities.
• Strong conflict-resolution, analytical, decision-making, verbal, and written communication skills.
• Ability to work onsite at the Pittsburgh, PA offices.

Nice to have

• 15+ years of industry experience with FDA-regulated devices.

Culture & Benefits

• Work focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive employee benefits.
• Evening and weekend work may occasionally be required.