Senior Design Assurance / Quality Engineer

Nuwellis, Inc. • Eden Prairie, MN

3d • $115,000 - $140,000 • Onsite

About The Position

We’re looking for a Senior Design Assurance / Quality Engineer to help ensure our products meet the highest standards for safety, quality, and regulatory compliance. In this role, you’ll partner closely with R&D, Clinical, Marketing, Regulatory, and Operations teams to support product development, design transfer, and continuous product improvements.
This role is ideal for someone who enjoys working cross-functionally and wants to play a key role in bringing innovative medical technologies from concept through commercialization.

This position requires prior experience working in a regulated medical device environment and hands-on experience with FDA Quality System Regulations and ISO 13485.

This is a full-time onsite position at our corporate headquarters in Eden Prairie, Minnesota.

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or another relevant engineering discipline.
• 5–8 years of experience in medical device design assurance or quality engineering within an FDA-regulated environment
• Experience working with: -Design controls (21 CFR 820.30) -ISO 13485 quality systems -ISO 14971 risk management -Design verification and validation

Nice To Haves

• Experience supporting software verification and validation
• Familiarity with biocompatibility, human factors, electrical safety, or sterilization standards
• Experience applying statistical tools to evaluate product reliability and process capability
• Strong analytical, communication, and problem-solving skills
• Ability to manage multiple projects and work effectively across cross-functional teams

Responsibilities

• Participate in design control activities in accordance with FDA 21 CFR 820.30
• Support design verification and validation activities
• Help maintain and organize Design History Files (DHF)
• Partner with engineering teams to develop test plans, specifications, and design documentation
• Support design transfer to manufacturing
• Lead risk management activities in accordance with ISO 14971
• Develop and maintain risk management plans, hazard analyses, and FMEA documentation
• Ensure risk management is integrated throughout the product lifecycle
• Review and approve change requests related to product development activities
• Support validation efforts related to test methods, equipment, packaging, labeling, and sterilization
• Apply statistical tools such as SPC, DOE, and Gage R&R to evaluate data and improve processes
• Help maintain compliance with ISO 13485 and FDA Quality System Regulations
• Participate in internal audits and support regulatory inspections
• Support Corrective and Preventive Action (CAPA) activities
• Help ensure the organization maintains a state of readiness for regulatory inspections
• Work cross-functionally with engineering, operations, regulatory, and clinical teams
• Support supplier quality activities including supplier qualification and monitoring
• Identify trends in quality data and support improvement initiatives

Benefits

• Annual bonus (discretionary)
• Health insurance (multiple plan options), including an HDHP with an annual company contribution of $2,000 (individual) / $4,000 (family)
• Company contribution toward dental and vision coverage
• Employer-paid: life insurance (up to 1x annual salary), short- and long-term disability
• PTO, floating holidays, + 8 company holidays
• 401(k) plan with a 3% company match

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level