Summary of Responsabilities & Duties
Provide design assurance support for on market medical devices.This role will be responsible to facilitate the application of design controls while supporting manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
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 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 coordinating Health Risk Assessment team with support of lead / manager when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situaton, including problem definition and impact.
Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
Participate on new product development projects as needed, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm input requirements are met.
Test method validation would be an element of assuring verification / validation is acceptable.
Drive for Results
Integrity & Trust
Education : Bachelor Degree life sciences, engineering or related disciplines
Language : Advanced English level
Experience : 2 years experience preferably in medical device industry
Specialized Acknowledge : Working knowledge ofFDA Quality Systems Regulation, especially Design Control requirements, ISO13485 and Medical Device Directive.
Working knowledge of ISO 14970, Risk Management
Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging and Biocompatibility standards and requirements.
Working knowledge of verification and validation requirements for regulated product
Familiarity with requirements analysis, including development of testable and measurable specifications.
Ability to effectively work on project teams
Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and the ability to effectively communicate assessment
Preferred : Familiar with test method validation, root cause failure analysis, statistical methods and design of experiments.
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