Senior Design Assurance Engineer

Description

Onsite
 

Organizational Relationships: Works with Divisional personnel and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering

Job Summary

• Provide design assurance support for new product development and on market medical devices.

Essential Duties

Duties are listed in order of greatest importance.

• The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
• Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Test method validation would be an element of assuring verification/validation is acceptable.
• Participate independently in doing thorough reviews/audit of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
• Participate independently on thorough reviews/audit Requirements Trace Matrix and assuring the trace matrix is accurate and meeting design control requirements for medical devices.

Qualifications

Education

• Technical Bachelor Degree

Experience

• 2-5 years’ experience preferably in medical device industry

Skills

• Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
• Experienced with ISO 14971, Risk Management
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for a regulated product
• Working knowledge of requirements analysis, including development of testable and measurable specifications