Product Quality Sr Designer I

Quick Facts

• Role: Product Quality Sr Designer
• Focus: Refining existing documentation and ensuring continued regulatory alignment to support new and existing products
• Travel: < 10%
• Compensation: $80,000–100,000 base salary plus performance bonus

Description

As a Product Quality Sr Designer, you will play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products. You will define the design approach, translate user needs into verifiable engineering requirements, support verification and validation testing, and maintain regulatory-compliant documentation and traceability.

Responsibilities

System Design

• Define the design approach aligned with product objectives, user needs, clinical workflows, and system performance
• Translate user needs into engineering level requirements that are objectively verifiable
• Lead design discussions and technical reviews; evaluate alternatives and trade-offs
• Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability

System Testing

• Implement and review product verification and validation (V&V) testing
• Develop software specifications, test protocols, and test cases
• Perform manual and automated testing; document results accurately

Product Documentation

• Collaborate with QA, Service, Compliance, and Regulatory teams for documentation requirements and cross-functional alignment
• Create, review, and maintain risk management files including cybersecurity risks
• Ensure product requirements are documented, traceable to verifiable tests, and maintained
• Ensure compliance with FDA, ISO, and internal design controls
• Maintain the Design History File (DHF) complete, accurate, and regulatory-compliant; address gaps proactively

Requirements / Qualifications

• Bachelor’s Degree and 4 years of relevant experience or equivalent experience
• Strong experience with Software as a Medical Device (SaMD)
• Strong experience in design controls in a multi-disciplinary organization
• Experience drafting and maintaining DHF content including user needs, design inputs, design outputs, traceability matrices, and risk documentation
• Ability to support risk analysis (e.g., uFMEA) and contribute to usability planning and design mitigations
• Familiarity with ISO 14971 required; IEC 62366 preferred
• Ability to define testable requirements, support V&V protocol development, and ensure traceability with the Product Development team
• Experience in a regulatory environment with strict compliance
• Experience with Codebeamer, Jira, or similar

Benefits

• Flexible working environment
• Location specific competitive total rewards
• Wellness incentives
• Robust employee resource groups (ERGs)
• Development opportunities
• Culture of recognition and performance awards