Senior Quality Engineer (Medical Devices)

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

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

Company

hirify.global develops healthcare technologies, including implantable cardiac and neuromodulation medical devices, with operations across more than 150 countries.

What you will do

• Develop, apply, and maintain quality standards, protocols, procedures, and compliance systems for manufacturing processes.
• Partner with engineering, operations, manufacturing, customer, and design teams to ensure quality standards and design outputs support production.
• Support equipment development, process characterization, IQ, OQPQ, process validation, and test method development and validation.
• Use statistical analysis, acceptance criteria, design of experiments, and comparison testing to develop compliant test plans and reports.
• Lead or support CAPA, nonconformance, corrective action, risk assessment, process FMEA, and change control activities.
• Coordinate cross-functional investigations, quality metrics, technical meetings, documentation, containment, and effectiveness verification.

Requirements

• Bachelor’s degree in engineering, science, or a technical field with at least 4 years of relevant experience; or a master’s degree with at least 2 years; or a PhD with no required experience.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not offered for roles below Principal level.
• Experience in engineering and/or quality, with knowledge of quality systems, manufacturing processes, and regulatory requirements.
• 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).

Nice to have

• Experience with electronics manufacturing, wafer fabs, microelectronics assembly, SMT, or chip-and-wire operations.
• Experience with medical device manufacturing, process quality, process engineering, audits, ISO, FDA-GMP, FDA, MDSAP, or TUV requirements.
• Six Sigma, Lean Sigma, DRM, or DFSS certification.
• Strong statistical analysis, DOE design and execution, technical writing, presentation, and communication skills.

Culture & Benefits

• Onsite collaboration and cross-functional work at the Tempe campus.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and incentive plans.
• Tuition assistance, employee stock purchase plan, employee assistance program, and global well-being resources.