Senior Systems Engineer (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical technologies and surgical solutions intended to improve outcomes for patients with musculoskeletal disorders.

What you will do

• Lead system architecture and design for Class III implantable spinal cord stimulation and neuromodulation systems with wireless Bluetooth interfaces.
• Convert stakeholder, customer, and performance requirements into system solutions while balancing technical, cost, and schedule constraints.
• Define requirements for algorithms and features and facilitate their transition into projects through clinical review and evaluation.
• Lead human factors engineering, including user needs, use scenarios, user profiles, environments, and interface requirements.
• Lead system integration testing, troubleshooting, root-cause analysis, and system-level verification and validation.
• Provide technical guidance, coordinate systems engineering activities, and report progress to the PMO.

Requirements

• Bachelor’s degree in software, computer, biomedical, electrical, or systems engineering, computer science, or an equivalent field; relevant experience may substitute for the degree.
• Relevant medical device development or verification experience: 8 years with a bachelor’s degree, 6 years with a master’s degree, or 3 years with a PhD.
• Experience with systems engineering, stakeholder needs, use cases, requirements definition and decomposition, functional architecture, and system design.
• Experience in a regulated industry and producing product requirements, specifications, engineering reports, test plans, procedures, and validation documentation.
• Strong communication, presentation, stakeholder alignment, decision-making, and cross-functional collaboration skills.
• Willingness to travel up to 10% as needed.

Nice to have

• Class III medical device experience.
• RF communications systems experience.
• Human factors and usability engineering, risk management, and medical device cybersecurity experience.
• Project management experience, including planning, estimation, milestones, resources, and budgets.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and decisive execution.
• Responsibilities support compliance with United States and international medical device regulations.
• Equal employment opportunity and an inclusive, respectful workplace are emphasized.
• Reasonable accommodations may be provided for qualified individuals with disabilities.