Principal Design Quality Engineer (MedTech)

TL;DR

Principal Design Quality Engineer (MedTech): Ensuring the safety and efficacy of AI-driven software medical device products with an accent on regulatory compliance and risk management. Focus on maintaining the Design History File, overseeing the agile SDLC, and implementing V&V protocols to meet ISO and FDA standards.

Location: Virtual US (Must be based in the United States)

Salary: $145,000 - $160,000 base salary + 15% target annual bonus

Company

A healthcare company revolutionizing heart disease diagnosis and tracking through AI-driven precision diagnostic solutions.

What you will do

• Act as the design quality engineering lead on software development project teams to ensure QMS and regulatory compliance.
• Review and approve design documentation, including user needs, requirements, architecture, and V&V plans/reports.
• Facilitate and maintain risk management activities according to ISO 14971 throughout the product lifecycle.
• Maintain the Design History File (DHF) to ensure readiness for audits and regulatory inspections.
• Provide quality oversight for the SDLC within an agile development environment.
• Support the investigation of design-related complaints and contribute to CAPA activities.

Requirements

• 12+ years of experience in Design Quality or Quality Engineering within the medical device industry, specifically with SaMD.
• Must be based in the United States.
• Bachelor's degree in engineering, computer science, or a related discipline.
• Practical knowledge of ISO 13485, IEC 62304, and ISO 14971.
• Strong understanding of FDA 21 CFR Part 820 and familiarity with EU MDR.
• Experience with GitHub, TestRail, and CI/CD pipelines.

Nice to have

• ASQ certification (e.g., CSQE, CQE).

Culture & Benefits

• Remote-first work environment with travel to US offices expected approximately twice per year.
• Competitive compensation including a 15% target annual bonus and stock options.
• Culture built on HEART values: Humility, Excellence, Accountability, Remarkable, and Teamwork.
• Comprehensive rewards package including paid benefits and employee perks.