Staff Hardware Quality Engineer — MDR Readiness

EnChannel Medical LTD; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

EnChannel Medical is seeking a Quality Engineer, Staff (Hardware) to lead design controls remediation for catheter-based hardware, build a compliant DHF, and partner with R&D to prepare for FDA and EU MDR submissions.

You will work with engineering, manufacturing, regulatory and clinical teams to identify risks, close gaps, support audits and inspections, and reinforce a scalable quality culture in a startup-like environment.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, or related 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.

Responsibilities

• Lead design controls remediation for catheter and hardware systems, including: Defining and structuring the Design History File (DHF), Identifying and closing documentation gaps, Aligning design reviews, approvals, and traceability.
• Partner closely with R&D, catheter design, and process development teams to translate outputs into Design Inputs/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 readiness, including preparation of objective evidence, audit trails, and regulator facing documentation.
• Support FDA inspections and external audits, including internal readiness activities.
• Review and contribute to risk management activities, including hazard analysis, FMEA, and linkage to design and process controls.
• Apply hardware and device quality expectations aligned with FDA Design Controls, ISO 13485, ISO 14971.
• Act as a quality execution partner to engineering teams, reinforcing compliance.
• Support transfer activities as designs mature toward manufacturing readiness.
• Escalate gaps, risks, and systemic issues to Quality leadership with evidence-based recommendations.

Skills

Design controls

Regulatory submissions

Risk management

Documentation remediation

FDA inspections

Education

Bachelor’s degree in Engineering

Job description

EnChannel Medical is seeking a Quality Engineer, Staff (Hardware) to lead design controls remediation for catheter-based hardware, build a compliant DHF, and partner with R&D to prepare for FDA and EU MDR submissions.

You will work with engineering, manufacturing, regulatory and clinical teams to identify risks, close gaps, support audits and inspections, and reinforce a scalable quality culture in a startup-like environment.