Sr. Quality Engineer

Nuwellis • Eden Prairie, MN

1d • 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. As part of a lean team in Eden Prairie, Minnesota, the role 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 position combines practical quality-engineering work with broader improvement initiatives. The engineer will manage competing priorities, exercise independent judgment within their areas of responsibility, and may take on additional ownership as experience grows.

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 the following: 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 complaint investigation findings to risk-management activities and analyze complaint trends to identify improvement opportunities.
• 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.
• Use problem-solving and data analysis to implement quality improvements.

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.
• 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