Senior Design Assurance / Quality Engineer

Nuwellis • Eden Prairie, MN

2d • $115,000 - $140,000 • Onsite

About The Position

Nuwellis, Inc. is a medical device company focused on improving the lives of patients suffering from fluid overload through our Aquadex SmartFlow ultrafiltration therapy. Our team is passionate about developing technology that helps clinicians treat critically ill patients more effectively. At Nuwellis, engineers work closely with clinical, regulatory, and operations teams to bring meaningful medical innovations to market.

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

• Support Product Development
• 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
• Drive Risk Management
• 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
• Provide Quality Engineering Support
• 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
• Support the Quality System
• 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
• Collaborate Across Teams
• 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
• Number of Employees: 1-10 employees