Senior Software QA Engineer – Medical Devices

Starkey Hearing Technologies; Eden Prairie (MN); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan with company-m

Company-paid life and short-term

Job summary

Starkey Hearing Technologies is hiring a Software Quality Assurance Engineer II at our global headquarters in Eden Prairie, MN. The role focuses on ensuring software and firmware quality across the product lifecycle, adhering to IEC 62304 and ISO 13485, and collaborating with R&D, Regulatory, and Marketing teams to deliver safe, compliant hearing technology.

You will lead QA activities for both product-related software and non-product systems, develop test strategies, and drive continuous

Qualifications

• Minimum 4-year college degree (MS preferred) in Computer Science/Software/Electrical/Electronic Engineering or equivalent required.
• Minimum 5 years of software development / quality assurance required.
• Experience with medical device regulations and quality systems is preferred.

Responsibilities

• Ensure software/firmware meets international standards and regulatory requirements throughout the product lifecycle.
• Define test strategies with software/firmware teams to verify performance and function.
• Understand and apply risk management concepts to product firmware/software.
• Coordinate testing and design reviews with Design Engineering during new product development.
• Maintain compliance documentation for audits and regulatory inspections.

Skills

Analytical thinking

Problem solving

People skills

Collaboration

Written and verbal communication

Judgment and decision making

Education

4-year degree (MS preferred) in CS/Software/Electrical/Electronic Eng

Job description

Starkey Hearing Technologies is hiring a Software Quality Assurance Engineer II at our global headquarters in Eden Prairie, MN. The role focuses on ensuring software and firmware quality across the product lifecycle, adhering to IEC 62304 and ISO 13485, and collaborating with R&D, Regulatory, and Marketing teams to deliver safe, compliant hearing technology.

You will lead QA activities for both product-related software and non-product systems, develop test strategies, and drive continuous