Sr Design Quality Engineer (Medical Devices)

Location: Hybrid role based in the San Francisco office, with in-person attendance three days per week for a full typical business day.

Annual salary: $156,000–$214,500, plus equity and benefits.

Company

hirify.global develops AI-powered, human-centered healthcare technology for musculoskeletal conditions, including personalized care and post-surgical rehabilitation products.

What you will do

• Guide design quality across product development programs from user needs and design inputs through design outputs, verification, validation, commercialization, and design transfer.
• Review requirements, design records, risk documentation, development plans, architectures, drawings, interfaces, usability considerations, and risk controls for quality and compliance gaps.
• Create and maintain complete, accurate, traceable, inspection-ready design history file records.
• Develop and review risk-based verification and validation protocols, reports, acceptance criteria, traceability, and objective evidence.
• Partner with engineering, product, manufacturing, purchasing, test, supplier engineering, program management, and Regulatory Affairs on scalable designs, process validation, production readiness, configuration control, submissions, audits, and regulatory responses.
• Coach engineering teams and improve quality workflows, templates, instructions, reliability practices, data analysis, protocol development, and design-for-quality methods.

Requirements

• Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering, mathematics, physics, or a related technical field.
• 6+ years of experience in quality engineering or a related field, including at least 4 years in a medical-device design and development environment.
• 3+ years applying design controls and risk management from early design and development through commercialization, including electromechanical systems and applicable standards: ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820.
• Experience navigating a quality management system with minimal oversight across individual product development projects.
• Ability to make balanced risk decisions, build consensus, and resolve complex technical challenges.
• Ability to communicate complex quality, technical, and regulatory information to engineers, cross-functional partners, and executive management.
• Experience coaching, mentoring, or teaching engineering teams in design quality, data analysis, protocol development, reliability, or design-for-quality methods.

Nice to have

• Advanced degree in engineering, mathematics, physics, or a related technical field.
• Experience with software as a medical device (SaMD) and software in a medical device (SiMD).

Culture & Benefits

• Inclusive medical, dental, and vision coverage, including support for gender-affirming care, family and fertility planning, and healthcare travel reimbursements where applicable.
• Traditional or Roth 401(k) options with a 2% company match.
• Learning and development stipend.
• Employee stock purchase plan with discounted company stock.
• Dog-friendly San Francisco office.