Principal Systems Engineer (Medical Devices)

Location: San Jose, California, United States

Annual salary: $144,400.00 to $21,600.00, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including defibrillators, patient monitors, ventilators, trauma kits, and temperature management solutions.

What you will do

• Establish and refine system-level requirements for new and enhanced products with project and program management.
• Lead system architecture and design, including subsystem partitioning, specifications, interfaces, and documentation.
• Make hardware, software, mechanical, cost, time, performance, and safety trade-offs against clinical, reliability, manufacturability, serviceability, regulatory, and business objectives.
• Lead implementation activities, resolve subsystem performance and interface issues, and address cross-functional system-level design problems.
• Oversee subsystem integration and verification testing to ensure performance, safety, cost, and system integration requirements are met.
• Advise engineering teams on system engineering principles, product requirements, risk management, and changes to existing product designs.

Requirements

• Advanced engineering degree with training and experience in systems, electronics, software, and mechanical engineering.
• 15+ years of experience developing electronic hardware and embedded software systems or subsystems for complex, real-time measuring instruments, including 10+ years as a Systems Engineer leading architecture and systems engineering for complex, real-time medical measuring instruments.
• 7+ years leading systems engineering for multiprocessor-based systems incorporating analog/digital electronics and embedded real-time software.
• Project management experience and training.
• Extensive experience designing and developing multiprocessor-based medical instruments with biomedical signal acquisition and processing electronics and embedded software.
• Ability to translate high-level product requirements into system- and subsystem-level specifications and designs, and to lead architecture, integration, and verification of portable, battery-operated measuring or patient-treatment systems.
• Working knowledge of analog signal acquisition, digital and microprocessor systems, power supplies, embedded real-time software, digital signal processing, real-time operating systems, analog/digital control systems, displays, batteries, data storage, and wireless communications.
• Working knowledge of mechanical engineering issues and processes involving electronics packaging, small moving mechanisms, molding, and machining.
• Ability to independently evaluate electronic circuitry, software, and mechanical designs using drawings, schematics, source code, technical education, and experience.
• Understanding of engineering project management, human factors in medical-device use, and FDA and European Community medical-device regulations and standards.
• Excellent verbal and written communication skills, with demonstrated technical decision-making and people-management or leadership success in a matrix environment, plus business acumen.
• Must not require hirify.global immigration sponsorship now or in the future, including H1B, TN, STEM, or OPT sponsorship.

Culture & Benefits

• Work in a mission-driven medical technology environment focused on improving patient outcomes and serving underserved patients.
• Culture values innovation, self-motivation, and an entrepreneurial spirit.
• Annual bonus eligibility under the company bonus plan.
• Comprehensive benefits plans are available.
• Applications are accepted on an ongoing basis until the position is filled.