Principal Design Quality Engineer

The Principal Design Assurance & Quality Engineer partners with Marketing Clinical Regulatory R&D and Operations and has the responsibility to provide Quality representation on teams facilitating front-end design design transfer to manufacturing and process/product improvements. This position is responsible for product safety and quality in all stages of product and process development and ensuring compliance to design specifications ISO FDA and all applicable regulatory requirements. This position is also responsible for implementation and maintenance of Quality System procedures related to operations document and record control customer feedback/complaint handling and internal and external audits to assure compliance to Quality System Regulations (QSR) ISO and other applicable requirements.

This is an onsite position requiring a full-time in-person presence at Nuwellis corporate office in Eden Prairie MN.

ESSENTIAL DUTIES AND 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.
  

MINIMUM QUALIFICATIONS

• 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.