Senior Design Assurance Leader — Medical Devices

HISTOSONICS INC; Plymouth (MN); On-site; USD 150,000 - 175,000; Full time

Benefits offered by this job

Health, dental, and vision insurance

Life, short-term and long-term DI

401(k)

Job summary

HistoSonics is seeking a Principal Design Assurance Engineer in Plymouth, MN. This expert-level role leads design assurance strategy across the medical device portfolio, with emphasis on IEC 62304 software, working with product teams to translate user needs into qualified design requirements and launch plans.

You will partner with Regulatory, R&D, and Product Development, define verification and validation approaches, and mentor engineers on standards compliance, risk management, and design

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• 10+ years of progressive quality or design assurance engineering experience in medical devices.
• Expert-level competency across the design control lifecycle and IEC 62304.

Responsibilities

• Lead design assurance strategy across the product portfolio.
• Define verification and validation strategy and drive it to closure with protocols and reports.
• Partner with Software Design Assurance and other teams across the SDLC per IEC 62304 and ISO 14971.
• Play a key role in design reviews to support phase closure and transfer to commercialization.
• Support product safety risk management and drive systemic improvements.
• Review design documentation to ensure compliance and technical accuracy.
• Mentor engineers on regulatory standards and design/process improvements.
• Participate in usability engineering activities and define evaluation protocols.
• Influence design robustness and safety through rigorous problem-solving.
• Work with suppliers on inspection plans and measurement methodologies.
• Assist audits and inspections as SME for risk management and non-product software validation.

Skills

Design assurance

Quality engineering

Medical devices

IEC 62304

SOUP management

Software verification & Validation

Software safety classification

Software risk management

Agile / SAFe

Regulatory compliance

Education

Bachelor’s degree in Engineering, Computer Science, or related technical discipline

Job description

HistoSonics is seeking a Principal Design Assurance Engineer in Plymouth, MN. This expert-level role leads design assurance strategy across the medical device portfolio, with emphasis on IEC 62304 software, working with product teams to translate user needs into qualified design requirements and launch plans.

You will partner with Regulatory, R&D, and Product Development, define verification and validation approaches, and mentor engineers on standards compliance, risk management, and design