Job Summary

• Provide design assurance support for new product development and on market medical devices.
• This role will be responsible to facilitate the application of design controls while supporting product development, manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

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.
• Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

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
• Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment

Preferred:

• Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment