Senior Software DA Engineer

Real; Plymouth (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Real is seeking a Sr. Design Assurance Engineer to support new product development and ensure design controls, DHF compliance, software quality (IEC 62304), risk management, and V&V activities for innovative medical devices.

The role collaborates with R&D, Regulatory, and Engineering teams to elevate product quality, safety, and reliability across hardware, software, and systems. EOE statements apply; base benefits may vary by location.

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.
• Experience working in cross-functional product development teams.

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, 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

DHF

V&V

Risk management

IEC 62304

ISO 14971

FDA QSR

ISO 13485

IEC 60601

IEC 62366

Education

Bachelor's degree

Job description

The Sr. Design Assurance Engineer supports new product development by ensuring products meet design, quality, regulatory, and safety requirements. The role focuses on design controls, risk management, verification and validation (V&V), design reviews, and Design History File (DHF) compliance. A key responsibility is supporting medical device software development in compliance with IEC 62304 and ISO 14971, while also contributing to hardware and system-level quality assurance activities.

Key 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, and other applicable standards.
• 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.

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.
• Experience working in cross-functional product development teams.

This is a senior Design QA role focused on driving design controls, DHF compliance, software quality assurance (IEC 62304), risk management, and V&V activities for innovative medical device product development.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.