Quality Engineer, Staff (Hardware)

About the role

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 execution-focused role translates defined quality strategy, policies, and regulatory expectations into complete, auditable design control deliverables. The initial focus will be assessing existing development artifacts, structuring a compliant Design History File (DHF), and partnering closely with R&D to prepare for FDA and EU MDR submissions. Ideal for an experienced quality professional who thrives in ambiguity, enjoys building compliant systems from imperfect starting points, and is comfortable supporting 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.

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 existing development outputs (e.g., drawings, specifications, test methods, prototypes) into compliant:
  • Design Inputs and Design Outputs
  • Verification and Validation (V&V) evidence
  • 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
  • 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

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

Preferred Skills

• Experience with supporting catheter design and development, manufacturing processes, and testing, such as:
  • 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

Pay

Pay ranges are determined by role, level, and location. The range displayed reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, job-related skills, experience, and relevant education or training.