Principal Design Assurance Engineer

Description

Position Summary

The Principal Design Assurance (DA) Engineer is a pivotal core member of the new product development (NPD) team responsible for delivering the next generation of medical devices to the market. The DA engineer leads project reliability and quality engineering activities, provides associated project deliverables, critically reviews the product design and documentation and then provides technical feedback to the team, and ensures quality system compliance throughout the NPD process. This will require frequent and collaborative interaction with cross-functional teams and personnel.

Job Responsibilities

The Principal Design Assurance Engineer is responsible for and has authority that includes:

• Establish and provide reliability and quality engineering guidance and education to cross-functional engineering staff and technical personnel.
• Ensure compliance with external and internal requirements related to medical device design and development, good manufacturing practices, and risk management.
• Serve as a fully engaged and collaborative member of new product development (NPD) and continuation engineering teams by providing innovative ideas and reliability and quality engineering guidance.
• Employ a practical approach to design assurance and quality by providing technical solutions which are imaginative, thorough, practicable, and consistent with project needs and organizational objectives while maintaining regulatory compliance.
• Actively support product development projects by coaching teams to create project development plans, design inputs and outputs, design history files, risk management, test strategies and traceability, and verification and validation plans.
• Support usability engineering and human factors studies to ensure device use errors are minimized or mitigated through standardized approaches.
• Provide design assurance support for post market surveillance processes when design changes are required.
• Complete assigned project deliverables that meet all requirements and are on time.
• Review and approve design and test method verification and validation plans, protocols, and reports. Ensure that test methods are appropriate, adequate, and validated to achieve planned confidence and reliability limits.
• Actively participate in design reviews and verify completion of all required phase activities and deliverables.
• Ensure a robust device design by providing effective reliability analysis and test approaches at the component, subassembly, device, and system levels.
• Identify and evaluate device design, performance, and test requirements propagated by relevant medical device industry, regulatory, and safety organizations to ensure compliance and obtain needed approval, certification, or other authorization.
• Supervise or execute the investigation, risk assessment, disposition, and correction of nonconforming product. Own all product-related CAPAs.
• Own, drive, and manage risk management activities related to product design, use, and manufacturing and servicing processes. Support software risk management.
• Other duties as assigned.
  
  

Required Qualifications

• BS degree in Engineering (biomedical, software, electrical, mechanical).
• 10 years in the medical device industry (FDA or ISO regulated); 10 years as quality engineer supporting new product development or continuation engineering functions.
• Knowledgeable about medical device regulations, including 21 CFR Part 820 and ISO 13485.
• Experience with medical device software development and life cycle processes.
• Experience with medical device safety, including biocompatibility, human factors, hardware, ingress protection, electrical safety, EMC/ESD, stability, and simulated distribution.
• Proficient in applying design and test method validation methods and techniques, including design of experiments (DOE) and Gage R&R.
• Experience in applying the appropriate statistical techniques and parameters for a wide range of analyses, including component and design reliability, using statistical software (e.g., Minitab).
• Working knowledge of root cause analysis and continuous improvement techniques.
• Proficient in applying risk / failure analysis methods (FTA, FMEA).
• Foster a collaborative, partnering style with colleagues in all functions.
• Able to work or lead cross-functionally and contribute as an effective team player.
• Able to handle multiple tasks/projects and manage priorities accordingly.
• Effective verbal and written communication, analytical, and interpersonal skills.
  
  

Preferred Qualifications

• MS degree in Engineering.
• ASQ Certified Quality Engineer (CQE) or Reliability Engineer (CRE).
• Direct support of medical device regulatory submissions (PMA, 510(k), design dossier).
• Led or directly participated in regulatory agency audits / inspections, with positive results.
• Direct interaction with safety agencies and notified bodies.
• Proficient in MS Office applications (Excel, Word, PowerPoint).
  
  

Physical Requirements

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.