Sr. Quality Engineer

Nuwellis, Inc. • Eden Prairie, MN

12h • $100,000 - $120,000 • Onsite

About The Position

Nuwellis is seeking a Senior Quality Engineer to take on broader responsibility and hands-on work improving medical devices that support patients and clinicians. The role is part of a lean team in Eden Prairie, Minnesota, and works closely with the Director of Quality and Regulatory Affairs and cross-functional partners on quality challenges across new product development, manufacturing, and post-market activities. Regular on-site presence is an essential function of the role.

The engineer balances hands-on quality work with broader improvement initiatives, manages competing priorities, and exercises independent judgment within areas of responsibility. The role offers opportunities to expand experience across the product lifecycle and take on additional ownership as experience grows.

The position is primarily performed in an office and manufacturing environment. Work may involve sitting, standing, walking, computer work, lifting up to 20 pounds, and using required personal protective equipment in manufacturing, laboratory, or warehouse areas. Offers are contingent on successful completion of a background check and drug screening.

Requirements

• Bachelor’s degree in engineering, science, or a related technical field; equivalent medical-device quality experience may be considered.
• At least 5 years of quality engineering or quality assurance experience in a medical-device manufacturing or R&D environment.
• Working knowledge of QMSR, ISO 13485, medical-device quality systems, design controls, and related standards.
• Experience with one or more of CAPA, complaints, nonconforming material, supplier quality, internal audits, risk management, product returns, or validation.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to manage multiple priorities and work well with cross-functional teams.

Nice To Haves

• Experience with statistical methods, process capability, quality-data analysis, validation activities, supplier quality, and electromechanical medical devices.

Responsibilities

• Improve complaint intake and processing.
• Conduct returned-product investigations with cross-functional partners, contribute findings to risk-management activities, and analyze complaint trends to identify opportunities for improvement.
• Provide quality support for new product development planning, specification development, verification and validation testing, and product documentation.
• Manage corrective and preventive action (CAPA) records.
• Support nonconforming material handling and participate in supplier quality activities.
• Review and revise procedures, support audits, and contribute to change control activities.
• Help ensure manufacturing processes and resulting products meet applicable specifications and quality requirements.
• Manage competing priorities and exercise independent judgment within areas of responsibility.

Benefits

• Multiple health insurance plan options, including a high-deductible health plan with an annual company HSA contribution of $2,000 for individual coverage or $4,000 for family coverage.
• Company contribution toward dental and vision coverage.
• Employer-paid life insurance of up to 1X annual salary.
• Employer-paid short- and long-term disability.
• PTO, floating holidays, and 8 company holidays.
• 401(k) plan with a 3% company match.

What This Job Offers

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