Senior MedTech Product Assurance Engineer

HistoSonics, Inc.; Plymouth (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 quality activities for commercial production, including inspection, product release, nonconforming material handling, and risk management coordination with Design Assurance.

The role collaborates with Manufacturing and Supply Chain to ensure compliance with FDA 21 CFR 820, ISO 13485 and ISO 14971, conducts PFMEA, participates in CAPAs, reviews DHRs, and supports supplier quality while traveling up to 10%.

Qualifications

• Bachelor’s degree in engineering or related technical field.
• 5+ years of progressive quality engineering experience in Supplier Quality, Quality Operations, or Manufacturing Quality, ideally within the medical device industry or another highly regulated manufacturing environment.
• Effective communicator who can work independently and collaboratively across all levels of the organization in a fast-paced, evolving environment.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Experience with risk management, nonconforming material, and complaint handling systems.
• Experience with practical application of statistics for product inspection and testing.
• Experience with FDA 21 CFR Part 820, ISO 13485 and ISO 14971.
• Approximately 10% of travel required.

Responsibilities

• Leads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies.
• Supports supplier evaluation, auditing, and performance monitoring.
• Supports development of in-process and final product testing.
• Supports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test protocols.
• Leads PFMEA development and ongoing updates.
• Collaborates with design assurance and manufacturing engineering to ensure that procedures, practices, and documentation comply with applicable standards and regulations.
• Supports the transfer of specifications and processes to production during the design transfer phase.
• Supports equipment control and process validations.
• Reviews Device History Records (DHR) and completes product release.
• Leads nonconforming material review and documentation.
• Uses knowledge of statistics to support inspection, testing, and process validation activities.
• Performs product complaint analysis including associated risk management file reviews and updates.
• Acts as Subject Matter Expert during audits and inspections for product inspection, PFMEA, nonconforming material, and product complaint analysis.
• Develops, modifies, and maintains quality system procedures, work instructions, and forms.
• Support internal and external audit activities as needed.
• Lead CAPA investigations, action planning, and follow-up for assigned CAPAs.
• Maintains a safe and clean work environment.
• Other duties as assigned

Skills

Quality engineering

Inspection planning

Risk management

Regulatory compliance

Supplier quality

Statistical analysis

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in engineering or related technical field

Job description

HistoSonics, Inc. in Plymouth, MN, is seeking a Sr. Product Assurance Engineer to lead quality activities for commercial production, including inspection, product release, nonconforming material handling, and risk management coordination with Design Assurance.

The role collaborates with Manufacturing and Supply Chain to ensure compliance with FDA 21 CFR 820, ISO 13485 and ISO 14971, conducts PFMEA, participates in CAPAs, reviews DHRs, and supports supplier quality while traveling up to 10%.