Senior Product Assurance Engineer - MedTech Quality Leader

HistoSonics, Inc.; Minneapolis, Saint Paul (MN, MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k)

Paid time off

Job summary

HistoSonics, Inc. in Plymouth, MN is seeking a Sr. Product Assurance Engineer to lead production quality activities for commercial systems, including inspection, product release, nonconforming material handling, and product complaint analysis.

You will collaborate with Design Assurance, Manufacturing, and Supply Chain to ensure that procedures, documentation, and risk management meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 5+ years of progressive quality engineering experience in medical device manufacturing.
• Strong communication and collaboration across all levels of the org.
• Experience with risk management, nonconforming material, and complaint handling systems.
• Familiarity with FDA 21 CFR Part 820, ISO 13485 and ISO 14971.

Responsibilities

• Leads product inspection strategy and measurement development.
• Supports supplier evaluation, auditing, and performance monitoring.
• Manages PFMEA development and updates.
• Reviews Device History Records and completes product release.
• Acts as SME during audits and inspections for quality systems.

Skills

Effective communicator

Cross-functional collaboration

Detail-oriented

Statistical methods

Multitasking

Education

Bachelor’s degree in engineering

Job description

HistoSonics, Inc. in Plymouth, MN is seeking a Sr. Product Assurance Engineer to lead production quality activities for commercial systems, including inspection, product release, nonconforming material handling, and product complaint analysis.

You will collaborate with Design Assurance, Manufacturing, and Supply Chain to ensure that procedures, documentation, and risk management meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971.