Quality Engineer, Staff (Software)

Enchannel Medical • Irvine, CA

1d

About The Position

The Quality Engineer, Staff (Software) will play a hands-on, high-impact role in executing design controls remediation for capital system medical devices, operating within established quality system governance and strategic direction. This role is execution-focused and operates under the direction of Quality leadership, with responsibility for translating defined quality strategy, policies, and regulatory expectations into complete, auditable design control deliverables. The initial focus of this role will be to assess existing development artifacts, structure a compliant Design History File (DHF), and partner closely with R&D to prepare the organization for FDA and EU MDR submissions. This role is ideal for an experienced quality professional who thrives in ambiguity, enjoys building compliant systems from imperfect starting points, and is comfortable rolling up their sleeves to support FDA and EU MDR submission readiness. You will collaborate closely with software, systems, hardware, clinical, and regulatory partners while helping to shape a scalable quality culture aligned with both regulatory expectations and startup realities.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related technical field.
• 5+ years of Software Quality Engineering experience within the medical device industry.
• Demonstrated independent, hands-on experience remediating software design documentation, including DHF restructuring.
• Direct experience supporting software new product development.
• Experience supporting FDA submissions (IDE, 510(k), or PMA) or regulatory inspections.
• Strong working knowledge of FDA Design Controls (21 CFR 820.30 / QMSR alignment).
• Strong working knowledge of Software development lifecycle documentation.
• Strong working knowledge of Risk management and traceability.
• Strong working knowledge of IEC 62304, including software safety classification and lifecycle documentation.
• Strong working knowledge of IEC 62366, including user interface and usability considerations.
• Strong working knowledge of FDA Software Validation guidance.

Nice To Haves

• Comfortable operating in fast paced, evolving environments.
• Strong communicator able to bridge engineering execution and regulatory expectations.
• Highly organized, self-directed, and adaptable to shifting priorities.

Responsibilities

• Lead execution of software design controls remediation, including defining and structuring the Design History File (DHF), identifying and closing documentation gaps, and aligning reviews, approvals, and traceability.
• Partner closely with software and R&D teams to translate existing development outputs (e.g., architecture, requirements, test artifacts) into compliant Design Inputs and Design Outputs, Verification and Validation evidence, and Traceability matrices.
• Identify risks and prioritize critical documentation to meet regulatory timelines and commitments.
• Support FDA and EU MDR submission readiness, including preparation of objective evidence, audit trails, and regulator facing documentation.
• Support FDA inspections and external audits, including internal readiness activities and direct participation.
• Review and contribute to risk management activities, including hazard analysis, Software FMEA, and linkage to design and process controls.
• Apply defined software quality expectations aligned with IEC 62304 (Medical Device Software Lifecycle Processes), IEC 62366 (Usability Engineering), and FDA software and cybersecurity guidance.
• Act as a quality execution partner to engineering teams, reinforcing consistent application of established design controls and risk management practices.
• Escalate gaps, risks, and systemic issues to Quality leadership with clear, evidence‑based recommendations.

What This Job Offers

• Career Level: Senior