Senior Medical Device Design Assurance Engineer

Real Staffing; Iowa (LA); On-site; USD 90,000 - 120,000; Full time

Job summary

Specialist Staffing Group is seeking a Senior Design Assurance Engineer to support new product development in the medical device sector. The role focuses on design controls, risk management, and V&V, ensuring compliance with IEC 62304 and ISO 14971, while contributing to DHF and broader QA activities.

You will collaborate with R&D, Regulatory, and Engineering teams, lead or support design reviews, audits, and continuous improvement initiatives, and help ensure product safety, reliability, and

Qualifications

• Bachelor's degree and 5+ years of medical device quality engineering experience.
• Strong experience with design controls, DHFs, risk management, and V&V.
• Knowledge of IEC 62304 software lifecycle processes and ISO 14971 risk management.
• Familiarity with FDA QSR, ISO 13485, EU MDR, IEC 60601, and IEC 62366.

Responsibilities

• Support design controls throughout the product lifecycle.
• Define and review product requirements, V&V strategies, and acceptance criteria.
• Lead or support risk management activities and design reviews.
• Ensure compliance with IEC 62304, ISO 14971, FDA QSR, ISO 13485, EU MDR, IEC 60601, and IEC 62366.
• Review DHFs, requirements, specifications, and test documentation for compliance.
• Support software, hardware, and system-level verification and validation.
• Partner with R&D, Regulatory, and Engineering teams to improve product quality, safety, and reliability.
• Support audits, inspections, design transfer, and continuous improvement initiatives.

Skills

Design controls

Risk management

V&V

Cross-functional collaboration

Education

Bachelor's degree

Tools

IEC 62304

ISO 14971

FDA QSR

ISO 13485

Job description

Specialist Staffing Group is seeking a Senior Design Assurance Engineer to support new product development in the medical device sector. The role focuses on design controls, risk management, and V&V, ensuring compliance with IEC 62304 and ISO 14971, while contributing to DHF and broader QA activities.

You will collaborate with R&D, Regulatory, and Engineering teams, lead or support design reviews, audits, and continuous improvement initiatives, and help ensure product safety, reliability, and