Senior Design Assurance Engineer - MedTech Software

HistoSonics, Inc.; Minneapolis (MN); On-site; USD 120,000 - 180,000; Full time

Job summary

HistoSonics, Inc. seeks a Sr. Design Quality Assurance Engineer to support design assurance activities for product development, including establishing design requirements and testing strategies.

The role emphasizes medical device software under IEC 62304 and may extend to hardware and system design assurance. You'll work with Regulatory, R&D, and Product teams to implement robust verification/validation and risk management, ensuring conformance to internal, regulatory, and customer requirements

Qualifications

• Bachelor’s degree required.
• 5+ years of quality engineering in a manufacturing environment, preferably in a medical device.
• Strong experience with medical device software/firmware development lifecycle and IEC 62304.
• Familiarity with SAFe AGILE Framework for software development cycle.
• Ability to work within a team and as an individual contributor in a fast-paced environment.
• Experience with FDA Quality System Regulations, ISO 13485, EU MDR, ISO 14971, IEC 60601 series, IEC 62304, IEC 62366.

Responsibilities

• Define product design requirements and verification/validation criteria with cross‑functional teams.
• Ensure system architecture and testability are maintained throughout development.
• Support adherence to Design Controls and software safety classification per IEC 62304.
• Lead design reviews, risk management, and documentation review across projects.
• Collaborate with suppliers on product requirements and measurement methods.
• Assist in design transfer, design verification/validation plans, protocols, and reports.

Skills

Quality engineering

Medical device software

Regulatory compliance

Risk management

SAFe AGILE

Education

Bachelor’s degree

Tools

IEC 62304

FDA QSR/ISO 13485

ISO 14971

IEC 60601

Job description

HistoSonics, Inc. seeks a Sr. Design Quality Assurance Engineer to support design assurance activities for product development, including establishing design requirements and testing strategies.

The role emphasizes medical device software under IEC 62304 and may extend to hardware and system design assurance. You'll work with Regulatory, R&D, and Product teams to implement robust verification/validation and risk management, ensuring conformance to internal, regulatory, and customer requirements