Senior Quality Engineer (Medical Devices)

Location: Tempe, Arizona, United States; onsite 5 days per week

Salary: $98,400–$147,600 USD per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including implantable cardiac and neuromodulation medical devices, to improve patient health and extend life.

What you will do

• Develop, maintain, and apply quality standards, protocols, processes, and compliance systems for manufacturing.
• Partner with engineering, operations, manufacturing, customer, and design teams to ensure compliant design outputs and high product quality.
• Support equipment development, process characterization, IQ, OQ/PQ, and test method development and validation.
• Apply statistical analysis, acceptance criteria, design of experiments, and comparison testing to develop compliant test plans and reports.
• Lead or support risk assessments, process FMEA, CAPA investigations, change control, and nonconforming product investigations.
• Develop quality metrics, performance scorecards, issue reporting, and continuous improvement solutions.

Requirements

• Bachelor's degree in engineering, science, or a technical field with at least 4 years of relevant engineering or quality experience; alternatively, a master's degree with at least 2 years or a PhD with no experience required.
• Unrestricted U.S. work authorization is required at hiring and throughout employment; sponsorship is offered only for Principal-level roles and above.
• Experience applying quality principles, procedures, methodologies, and regulatory requirements in manufacturing environments.
• Knowledge of statistical analysis, design of experiments, process validation, test method validation, risk assessment, and corrective actions.
• Strong technical writing, presentation, communication, and cross-functional collaboration skills.

Nice to have

• Experience with electronics manufacturing, wafer fabs, microelectronics assembly, SMT, or chip-and-wire processes.
• Six Sigma, Lean Sigma, DRM, or DFSS certification.
• Experience with FDA, MDSAP, TUV, or other internal and external audits.
• Medical device manufacturing, process quality, or process engineering experience.

Culture & Benefits

• Onsite collaboration with engineering and operations teams at the Tempe campus.
• Health, dental, and vision insurance, with HSA and healthcare FSA options.
• 401(k) plan with employer contribution and match, incentive plans, paid time off, and paid holidays.
• Life insurance, disability coverage, employee assistance, tuition assistance, and dependent daycare spending account.
• Employee Stock Purchase Plan and global well-being program.