Design Quality Engineer

Katalyst CRO; Carlsbad (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a Senior Design Quality Engineer to lead design quality integration across acquired businesses and legacy quality systems within a large medical device program. You will partner with Engineering, Regulatory, Manufacturing, and Program Management to ensure compliant integration of design control processes and product development within the unified Quality Management System.

You will drive risk management, verification and validation strategies for hardware and software,

Qualifications

• Lead high-level Design Quality Engineering activities across complex medical device programs while ensuring compliance with FDA, ISO 13485, and global regulatory requirements.
• Work cross-functionally to develop and improve design control processes, risk management activities, and verification and validation strategies for hardware and software-based products.
• Oversee design reviews, risk assessments, traceability activities, and product development deliverables throughout the design lifecycle.

Responsibilities

• Lead high-level Design Quality Engineering activities across complex medical device programs while ensuring compliance with FDA, ISO 13485, and global regulatory requirements.
• Develop and improve design control processes, risk management activities, and verification and validation strategies for hardware and software-based products.
• Oversee design reviews, risk assessments, traceability activities, and product development deliverables throughout the design lifecycle.
• Provide technical leadership for quality and compliance initiatives tied to product development, remediation, sustaining engineering, and process improvement projects.

Skills

Design Controls

Risk Management

V&V

Root Cause Analysis

Process Improvement

Job description

Summary

Our client is a large medical device manufacturer currently undergoing a large-scale acquisition and integration initiative. They are currently seeking a Senior Design Quality Engineer to support design quality integration, remediation, and harmonization activities across acquired businesses and legacy quality systems. This individual will serve as a technical leader partnering closely with Engineering, Regulatory, Manufacturing, and Program Management teams to ensure compliant integration of design control processes and product development activities within the unified Quality Management System.

• This individual will be responsible for leading high-level Design Quality Engineering activities across complex medical device programs while ensuring compliance with FDA, ISO 13485, and global regulatory requirements.
• This person will work cross-functionally to develop and improve design control processes, risk management activities, and verification and validation strategies for both hardware and software-based products.
• Additional responsibilities include overseeing design reviews, risk assessments, traceability activities, and product development deliverables throughout the design lifecycle.
• This individual will provide technical leadership for quality and compliance initiatives tied to product development, remediation, sustaining engineering, and process improvement projects.
• They will also support integration of quality system requirements into engineering and product development workflows while helping mentor junior engineers and influence best practices across the organization.

Summary

Our client is a large medical device manufacturer currently undergoing a large-scale acquisition and integration initiative. They are currently seeking a Senior Design Quality Engineer to support design quality integration, remediation, and harmonization activities across acquired businesses and legacy quality systems. This individual will serve as a technical leader partnering closely with Engineering, Regulatory, Manufacturing, and Program Management teams to ensure compliant integration of design control processes and product development activities within the unified Quality Management System.

Roles & Responsibilities

• This individual will be responsible for leading high-level Design Quality Engineering activities across complex medical device programs while ensuring compliance with FDA, ISO 13485, and global regulatory requirements.
• This person will work cross-functionally to develop and improve design control processes, risk management activities, and verification and validation strategies for both hardware and software-based products.
• Additional responsibilities include overseeing design reviews, risk assessments, traceability activities, and product development deliverables throughout the design lifecycle.
• This individual will provide technical leadership for quality and compliance initiatives tied to product development, remediation, sustaining engineering, and process improvement projects.
• They will also support integration of quality system requirements into engineering and product development workflows while helping mentor junior engineers and influence best practices across the organization.

Requirements:

• Design Controls
• Mechanical/Electrical Engineering Background
• Risk Management
• DHF Remediation / Design Remediation
• Verification & Validation (V&V)
• Change Controls
• Root Cause Analysis / CAPA support
• Process Improvement.
• Working knowledge of electronic assemblies
• Acquisition or integration project experience