Senior Design Assurance Quality Engineer

Position Overview

Finish Line Staffing Services is seeking an experienced Senior Design Assurance Quality Engineer to support design controls, risk management, and quality engineering activities for medical device products, including catheter-based, software, and electromechanical systems.This role will collaborate with cross-functional teams throughout the product development lifecycle, from concept through commercialization, ensuring compliance with FDA regulations, ISO standards, and Quality Management System (QMS) requirements.

Key Responsibilities

• Lead Design Assurance activities for medical device development projects.
• Ensure compliance with design control and risk management requirements, including FDA and ISO standards.
• Facilitate risk assessments, hazard analyses, FMEAs, and risk management documentation.
• Support design verification and validation (V&V), new product introduction (NPI), and design transfer activities.
• Collaborate with R&D, Manufacturing, Regulatory, and Quality teams to ensure product quality and compliance.
• Support software quality activities in accordance with IEC 62304 and applicable cybersecurity requirements.
• Provide technical expertise in statistical analysis, failure investigations, and root cause analysis.
• Support post-market surveillance and continuous improvement initiatives.
• Maintain accurate design control, risk management, and regulatory documentation.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5–8 years of Design Assurance or Quality Engineering experience within the medical device or life sciences industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience with design controls, risk management, NPI, and design transfer.
• Familiarity with IEC 62304, IEC 60601, and ISO 10993 preferred.
• Experience with FMEA, SPC, root cause analysis, MSA, and Gage R&R.
• Knowledge of process validation (IQ/OQ/PQ) and regulatory documentation.
• Proficiency with statistical analysis tools such as Minitab preferred.
• Experience collaborating with external vendors and cross-functional teams.
• Strong analytical, organizational, communication, and problem-solving skills.