Senior Design Assurance Quality Engineer

Job Summary

Our client is seeking an experienced Senior Design Assurance Quality Engineer to lead Design Assurance and Risk Management activities across innovative medical device product families, including sterile catheter systems, software-enabled products, and electromechanical devices.

This highly collaborative role partners closely with Engineering, Manufacturing, Operations, Regulatory Affairs, Commercial, and Quality teams to ensure products are designed, developed, validated, and transferred into manufacturing in full compliance with FDA regulations, ISO standards, and internal Quality Management System (QMS) requirements. The ideal candidate will serve as the Design Assurance subject matter expert throughout the entire product lifecycle-from concept and development through commercialization and post-market surveillance.

Key Responsibilities

Design Assurance & Product Development

• Serve as the Design Assurance (DA) Lead on cross-functional product development programs.
• Ensure compliance with internal Design Control procedures and applicable regulatory requirements throughout the product lifecycle.
• Guide engineering teams in implementing Design Control and Risk Management best practices.
• Support all phases of product development, including concept, design, verification, validation, design transfer, and product launch.
• Review and approve Design Control documentation to ensure regulatory compliance and design integrity.

Risk Management

• Lead cross-functional Risk Management activities in accordance with ISO 14971.
• Facilitate:
  • Hazard Analyses
  • Failure Modes and Effects Analyses (FMEA)
  • Risk Management Plans (RMP)
  • Risk Management Reports (RMR)
  • Risk Management Files (RMF)
• Evaluate product risks and ensure appropriate mitigation strategies are implemented throughout development.

Verification, Validation & Design Transfer

• Support Design Verification and Validation (V&V) planning and execution.
• Ensure traceability between design inputs, outputs, verification, validation, and risk controls.
• Partner with Manufacturing, New Product Introduction (NPI), and R&D teams to ensure successful Design Transfer.
• Support manufacturing readiness and product commercialization activities.

Software & Product Quality

• Support software lifecycle quality activities in accordance with IEC 62304.
• Participate in product cybersecurity initiatives.
• Ensure software quality processes align with regulatory and company standards.

Quality Engineering & Continuous Improvement

• Serve as a subject matter expert for:
  • Statistical Analysis
  • Root Cause Analysis (RCA)
  • Failure Investigations
  • Risk Assessments
• Support Post-Market Surveillance (PMS) activities.
• Collaborate with third-party suppliers and vendors to ensure quality and compliance.
• Drive continuous improvement initiatives that strengthen product quality and regulatory compliance.

Required Qualifications

• Bachelor's Degree in Engineering or a related technical discipline.
• Minimum 5 8 years of Design Assurance or Quality Engineering experience within the medical device or life sciences industry.
• Experience supporting New Product Introduction (NPI) and Design Transfer.
• Strong working knowledge of:
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971:2019
• Experience supporting Design Controls throughout the complete product development lifecycle.
• Experience managing risk management activities and quality documentation.
• Strong communication, collaboration, and project leadership skills.

Preferred Qualifications

• Experience with:
  • IEC 62304 (Medical Device Software)
  • IEC 60601 (Medical Electrical Equipment)
  • ISO 10993 (Biocompatibility)
• Experience supporting regulatory submissions and documentation.
• Experience managing third-party suppliers and contract manufacturers.
• Experience working in highly regulated medical device manufacturing environments.

Technical Skills

Candidates should possess expertise in:

Quality & Regulatory

• FDA 21 CFR Part 820
• ISO 13485
• ISO 14971:2019
• Design Controls
• Risk Management
• Design Assurance
• Product Lifecycle Management
• Regulatory Documentation
• Post-Market Surveillance

Risk & Quality Engineering

• FMEA
• Hazard Analysis
• Root Cause Analysis (RCA)
• Statistical Process Control (SPC)
• Measurement Systems Analysis (MSA)
• Gage R&R
• Failure Investigations
• Corrective & Preventive Actions (CAPA)

Validation & Product Development

• Design Verification
• Design Validation
• IQ/OQ/PQ Validation
• Design Transfer
• New Product Introduction (NPI)

Software & Data Analysis

• Minitab
• Statistical Analysis
• Microsoft Office Suite
• Medical Device Software Quality (IEC 62304)
• Product Cybersecurity

Leadership & Professional Skills

• Proven ability to lead cross-functional project teams through influence.
• Strong organizational and project management skills.
• Excellent analytical and critical thinking abilities.
• Exceptional written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced product development environment.
• Self-motivated with a continuous improvement mindset.
• Strong interpersonal skills with the ability to build collaborative relationships across engineering, manufacturing, quality, and regulatory teams.

Working Conditions

• Primarily office environment with regular interaction in engineering laboratories and manufacturing facilities.
• Occasional work within controlled production environments requiring appropriate Personal Protective Equipment (PPE).
• Minimal travel may be required to support suppliers, manufacturing sites, or customer activities.