Principal Design Assurance Engineer

2 months ago

Eden Prairie, Minnesota, United States Nuwellis, Inc Full time
Job Title: Principal Design Assurance

Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.

Job Summary:

The Principal Design Assurance & Quality Engineer partners with Marketing, Clinical, Regulatory, R&D and Operations to provide Quality representation on teams facilitating front-end design, design transfer to manufacturing, and process/product improvements.

Key Responsibilities:
  • Provide effective quality engineering support in all aspects of the design and development phases in accordance with all applicable procedures, regulations and standards.
  • Review, initiate, and/or approve change requests associated with design verification & validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
  • Manage product development processes and procedures.
  • Manage design history file organization, deliverables, maintenance and associated procedures.
  • Manage the risk management process in accordance with ISO 14971, including risk management plans, hazard analyses, FMEAs, and risk management reports, throughout all product development phases.
  • Partner with other functional areas, primarily R&D, in areas such as preparing test plans, data analysis, specifications, risk analysis, and change implementation.
  • Interpret and contribute to electro-mechanical systems (electronics, pneumatics) and software design and testing.
  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Gage R & R, TMV, SPC, DOE).
  • Partner with engineering in test method development and validation.
  • Identify, apply, and update engineering, technical, and regulatory standard requirements for medical devices.
  • Maintain Quality System, especially compliance with ISO 13485, EU MDR 2017/745 and QSR 21 CFR 820.
  • Assist in management of regulatory agency inspections and certification/accreditation body audits.
  • Develop quality plans to ensure corporate and compliance objectives are met.
  • Manage receiving and final inspection process.
  • Oversee Material Review Board.
  • Ensure Corrective Actions are comprehensive, effective and timely.
  • Manage Document and Record Control, Training, CAPA, Change Control and Feedback and Complaint Systems.
  • Maintain working knowledge of existing and emerging regulations, standards and guidance documents applicable to the business.
  • Act as Quality liaison and representative with government agencies, their extensions and the business community, as needed.
  • Assist in ensuring the company is in a constant state of readiness for regulatory inspections.
  • Assure compliance and feedback information is summarized and communicated to Sr. Management in a timely periodic manner.
  • Oversight and management of supplier quality to support supplier selection and approval, audits and CAPA.
  • Identify and analyze quality trends and proposes and implements strategies and projects to maximize and optimize overall quality performance.
Requirements:
  • Bachelor's degree in Engineering or other relevant discipline.
  • 10 years of experience in quality and/or design assurance.
  • PREFERRED QUALIFICATIONS & COMPETENCIES
  • Master's in Engineering or related discipline.
  • ASQ CQE Certification.
  • 5 years of experience in the medical device industry.
  • 10 years of experience in an FDA or ISO regulated environment.
  • Experience with software design, verification, and validation.
  • Experience in biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards.
  • Proficient in driving risk management activities.
  • Experience in application of statistical methods to design reliability and process capability.
  • Effective verbal and written communication, analytical, and interpersonal skills.
  • Able to independently provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
  • Able to work or lead cross-functionally and contribute as an effective team player
  • Must be able to handle multiple tasks/projects and manage priorities accordingly
  • Practical approach to quality and a partnering style with colleagues in all functions of the business
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Proficient in MS Excel, Word, Power Point.

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