Principal R&D Engineer: NPD for Cranial, Spinal Technologies (Medical Devices)

Location: Fort Worth, Texas, United States

Salary: $131,200–$196,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies in areas including neurological and spinal care, serving patients in more than 150 countries.

What you will do

• Lead technical decisions within cross-functional teams developing new cranial and spinal products and product improvements.
• Develop system architectures, interface definitions, functional decompositions, technical specifications, and traceable product requirements.
• Translate clinical, user, business, regulatory, and technical inputs into measurable and verifiable system and subsystem requirements.
• Perform engineering analyses, trade studies, feasibility assessments, prototype development, testing, and troubleshooting across hardware, software, firmware, disposables, accessories, and manufacturing processes.
• Lead risk management, design verification, regulatory documentation, QMS improvements, and evaluation of external standards changes.
• Support project planning, manufacturing and laboratory tooling improvements, production lines, technical training, and mentoring of junior engineers.

Requirements

• Bachelor’s degree in mechanical engineering.
• At least 7 years of technically related experience with a bachelor’s degree in a STEM discipline, or at least 5 years of related experience with an advanced degree.
• Experience with mechanical or electromechanical product design, prototype or production component manufacturing, test methods, test execution, and technical reporting.
• Experience with QMS procedures, regulations, standards, risk management, and regulated product development.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• U.S. work authorization is required; H-1B, TN, and J sponsorship is offered for Principal-level roles and above.

Nice to have

• Experience with motor control, power management, sensors, instrumentation, data acquisition, and statistical analysis.
• Familiarity with IEC 60601, ISO 13485, FDA-regulated environments, 510(k) and PMA submissions.
• Experience with ProEngineer, material selection, tolerance analysis, GD&T, and statistical methods.

Culture & Benefits

• Purpose-driven healthcare work focused on alleviating pain, restoring health, and extending life.
• Health, dental, and vision insurance, health savings and flexible spending accounts, life insurance, and disability coverage for eligible regular employees.
• Paid time off, paid holidays, tuition assistance, employee assistance, and retirement benefits including a 401(k) with employer contribution and match.
• Employee Stock Purchase Plan, incentive plans, and global well-being resources.