Job Description

Job Responsibilities:

• 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.  

Skills:

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

Education/Experience:

• Bachelor's degree in mechanical engineering or electrical engineering

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