Katalyst CRO
Job Description
Provide design assurance support for new product development and on‑market medical devices. You will 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.
Responsibilities
Participate independently on new product development projects, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.
Review and audit Design History File (DHF) documentation for capital and disposable medical devices, including design plans, inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
Review and audit the Requirements Traceability Matrix, ensuring accuracy and compliance with design control requirements.
Participate in sustaining product projects, confirming continued meeting of product inputs and completion of necessary verification, validation, and risk‑management activities.
Collaborate with R&D to coordinate design elements of Risk Management files for product compliance with applicable standards.
Coordinate Health Risk Assessment team when evaluating on‑market products, demonstrating effective analysis and problem definition.
Assess change requests for product impact on design, determining supporting information required for implementation.
Requirements
Technical bachelor’s degree.
2–5 years of experience in the medical device industry.
Experience with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and the Medical Device Directive.
Experience with ISO 14971 and Risk Management.
Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards and requirements.
Knowledge of verification and validation requirements for a regulated product.
Knowledge of requirements analysis, including development of testable and measurable specifications.
Ability to work effectively on project teams and lead critical tasks to timely completion.
Ability to assess written product and project documentation as the principal advocate for compliance and communicate assessments effectively.
#J-18808-Ljbffr
Responsibilities
Participate independently on new product development projects, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.
Review and audit Design History File (DHF) documentation for capital and disposable medical devices, including design plans, inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
Review and audit the Requirements Traceability Matrix, ensuring accuracy and compliance with design control requirements.
Participate in sustaining product projects, confirming continued meeting of product inputs and completion of necessary verification, validation, and risk‑management activities.
Collaborate with R&D to coordinate design elements of Risk Management files for product compliance with applicable standards.
Coordinate Health Risk Assessment team when evaluating on‑market products, demonstrating effective analysis and problem definition.
Assess change requests for product impact on design, determining supporting information required for implementation.
Requirements
Technical bachelor’s degree.
2–5 years of experience in the medical device industry.
Experience with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, and the Medical Device Directive.
Experience with ISO 14971 and Risk Management.
Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards and requirements.
Knowledge of verification and validation requirements for a regulated product.
Knowledge of requirements analysis, including development of testable and measurable specifications.
Ability to work effectively on project teams and lead critical tasks to timely completion.
Ability to assess written product and project documentation as the principal advocate for compliance and communicate assessments effectively.
#J-18808-Ljbffr