Senior Quality Engineer — Medical Device, On-Site Impact

Nuwellis, Inc.; Eden Prairie (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health insurance

HSA contribution toward health plan

Dental and vision coverage

Life insurance (1X salary)

Disability insurance (short/long-term)

Paid time off & holidays

401(k) plan with match

Job summary

Nuwellis, Inc. in Eden Prairie, MN is seeking a Senior Quality Engineer to drive quality across new product development, manufacturing, and post-market activities.

You will work closely with the Director of Quality and Regulatory Affairs and cross‑functional partners to solve quality challenges and improve processes on-site. The role emphasizes hands-on work, data analysis, and broader quality improvements with opportunities to expand ownership as experience grows.

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field.
• 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 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.

Responsibilities

• Complaint Management — Improve complaint intake and processing, conduct investigations, contribute findings to risk management, and analyze trends.
• New Product Development — Provide quality support for development planning, verification and validation testing, and product documentation.
• CAPA and Supplier Quality — Manage 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 — Ensure manufacturing processes and products meet specifications and quality requirements.

Skills

Analytical skills

Documentation

Communication

Problem solving

Cross-functional teamwork

Education

Bachelor’s degree in engineering/science/related field

Job description

Nuwellis, Inc. in Eden Prairie, MN is seeking a Senior Quality Engineer to drive quality across new product development, manufacturing, and post-market activities.

You will work closely with the Director of Quality and Regulatory Affairs and cross‑functional partners to solve quality challenges and improve processes on-site. The role emphasizes hands-on work, data analysis, and broader quality improvements with opportunities to expand ownership as experience grows.