Lead Quality Assurance Engineer

2 weeks ago

Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time
Job Overview

Nuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.

The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial in providing Quality oversight on teams that facilitate early-stage design, transition to manufacturing, and enhancements in processes and products. The individual in this position is accountable for ensuring product safety and quality throughout all phases of product and process development, while adhering to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.

This position requires a full-time, onsite presence at Nuwellis' corporate office.

Key Responsibilities

  • Deliver comprehensive quality engineering support during all design and development phases, ensuring adherence to applicable procedures, regulations, and standards.
  • Review, initiate, and approve change requests related to design verification and validation, risk management, usability, biocompatibility, shelf life, and other critical areas.
  • Oversee product development processes and documentation.
  • Manage the organization and maintenance of design history files and associated procedures.
  • Lead the risk management process in compliance with ISO 14971, including the development of risk management plans and hazard analyses.
  • Collaborate with R&D and other functional areas in the preparation of test plans, data analysis, and specifications.
  • Interpret and contribute to the design and testing of electro-mechanical systems and software.
  • Utilize statistical tools for data analysis, acceptance decisions, and process capability improvements.
  • Identify and apply relevant engineering, technical, and regulatory standards for medical devices.
  • Maintain compliance with Quality System regulations, including ISO 13485 and EU MDR 2017/745.
  • Assist in managing regulatory inspections and audits from certification bodies.
  • Develop quality plans to meet corporate and compliance objectives.
  • Supervise the receiving and final inspection processes.
  • Manage the Material Review Board activities.
  • Ensure that Corrective Actions are thorough, effective, and timely.
  • Oversee Document and Record Control, Training, CAPA, Change Control, and Feedback Systems.
  • Stay informed on existing and emerging regulations and standards relevant to the industry.
  • Act as a Quality liaison with regulatory agencies and the business community as necessary.
  • Ensure the company is always prepared for regulatory inspections.
  • Summarize compliance and feedback information for senior management in a timely manner.
  • Manage supplier quality to support selection, approval, audits, and CAPA processes.
  • Analyze quality trends and propose strategies to enhance overall quality performance.

Qualifications

  • Bachelor's degree in Engineering or a related field.
  • A minimum of 10 years of experience in quality assurance or design assurance.

Preferred Qualifications

  • Master's degree in Engineering or a related field.
  • ASQ CQE Certification.
  • 5 years of experience in the medical device sector.
  • 10 years of experience in an FDA or ISO regulated environment.
  • Experience with software design, verification, and validation.
  • Familiarity with biocompatibility, human factors, electrical safety, and sterilization standards.
  • Proficient in risk management methodologies.
  • Experience applying statistical methods to enhance design reliability and process capability.
  • Strong verbal and written communication skills, along with analytical and interpersonal abilities.
  • Able to provide independent technical solutions to complex problems, ensuring alignment with organizational goals.
  • Effective in cross-functional collaboration and teamwork.
  • Capable of managing multiple tasks and prioritizing effectively.
  • Practical approach to quality and a collaborative style with colleagues across all functions.
  • Able to address inquiries or complaints from customers and regulatory bodies.
  • Proficient in Microsoft Excel, Word, and PowerPoint.

Equal Opportunity Employer: minority/female/disability/veteran

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