Quality Engineer, Staff (Hardware)

Enchannel Medical•Irvine, CA

About The Position

The Quality Engineer, Staff (Hardware) will play a hands on, high impact role in executing design controls remediation for catheter based 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 catheter design, process development, manufacturing, clinical, and regulatory partners while reinforcing a scalable quality culture aligned with both regulatory expectations and startup realities.

Requirements

Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, or related technical discipline)
5+ years of Quality Engineering experience within the medical device industry
Demonstrated independent, hands on experience with design documentation remediation, including DHF restructuring
Direct experience supporting catheter based or disposable medical device 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), Hardware and process development lifecycle documentation, Risk management and design traceability

Nice To Haves

Experience with supporting catheter design and development, manufacturing processes, and testing
Working knowledge and practical application of: ISO 14971 risk management, Design verification and validation for invasive devices, FDA guidance for intravascular or catheter-based devices
Comfortable operating in fast paced, evolving environments.
Strong communicator able to bridge hands on engineering execution and regulatory expectations.
Highly organized, self-directed, and adaptable to shifting priorities.

Responsibilities

Lead design controls remediation for catheter and hardware systems, including defining and structuring the Design History File (DHF), identifying and closing documentation gaps, and aligning design reviews, approvals, and traceability.
Partner closely with R&D, catheter design, and process development teams to translate existing development outputs (e.g., drawings, specifications, test methods, prototypes) into compliant Design Inputs and Design Outputs, Verification and Validation (V&V) evidence, and traceability matrices.
Identify risks and prioritize critical documentation to meet regulatory timelines and commitments.
Support FDA and EU MDR 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, FMEA, and linkage to design and process controls.
Apply defined hardware and device quality expectations aligned with FDA Design Controls and QMSR expectations, ISO 13485, and ISO 14971 risk management principles.
Act as a quality execution partner to engineering teams, reinforcing consistent application of established design controls and risk management practices.
Support transfer activities as designs mature toward manufacturing readiness.
Escalate gaps, risks, and systemic issues to Quality leadership with clear, evidence‑based recommendations.