Sr. Quality Engineer

Description

Nuwellis is seeking a Senior Quality Engineer ready to take the next step in their career through broader responsibility, meaningful autonomy, and hands-on work improving medical devices that support patients and clinicians. As part of our lean team in Eden Prairie, Minnesota, you'll work closely with the Director of Quality and Regulatory Affairs and cross-functional partners to solve quality challenges across new product development, manufacturing, and post-market activities.

This position requires regular on-site presence as an essential function of the role.

What You'll Do

• Complaint Management- 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.
• New Product Development- Provide quality support for development planning, specification development, verification and validation testing, and product documentation.
• CAPA and Supplier Quality- Manage corrective and preventive action (CAPA) records, support nonconforming material handling, and participate in supplier quality activities.
• QMS Management- Review and revise procedures, support audits, and contribute to change control activities.
• Manufacturing Quality Support- Help ensure manufacturing processes and resulting products meet applicable specifications and quality requirements.

This opportunity is well suited to a quality engineer with a solid foundation who enjoys problem-solving, data analysis, and seeing improvements through to implementation. You'll balance hands-on quality work with broader improvement initiatives, manage competing priorities, and exercise independent judgment within your areas of responsibility. You'll build on your existing strengths while expanding your experience across the product lifecycle, with opportunities to take on additional ownership as your experience grows.

Requirements

What We're Looking For

• 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.
• Exp erience with areas such as 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.

Preferred Experience

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

Work Environment

This role is primarily performed in an office and manufacturing environment. It may involve sitting, standing, walking, computer work, light lifting up to 20 pounds, and use of required personal protective equipment in manufacturing, laboratory, or warehouse areas.

Nuwellis offers a comprehensive benefits package, including:

• 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 + 8 company holidays
• 401(k) plan with a 3% company match

Any offer of employment is contingent upon successful completion of a background check and drug screening.

Nuwellis is an Equal Opportunity Employer, including minority, female, disability and veteran applicants.

Nuwellis participates in the federal E-Verify program to confirm employment eligibility.