Job Information
Bolder Surgical, LLC Senior Design Assurance Engineer in Louisville, Colorado
The Senior Design Assurance Engineer at Hologic, Inc. in Louisville, CO will provide design assurance support for new product development and on market medical devices. 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. Participate on new product development projects and sustaining product projects, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met. Perform verification, validation, and risk management activities. Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies. Coordinate with Health Risk Assessment team for evaluation of on market product, to complete analysis, problem definition and impact. Assess change requests of product for impact to design. Remote work permissible with at least 3 days in the office. Minimum Requirements: Bachelor's Degree in Materials Engineering, Mechanical Engineering, Manufacturing Engineering, or other related technical related field and One year of engineering experience working in the medical device industry. One year of experience must include experience with each of the following: (1) Experience with FDA Quality System Regulations, including Design Control requirements, ISO 13485 and Medical Device Directive; (2) Experience with ISO 14970, Risk Management; (3) Experience with Usability, Reliability, Sterilization, Packaging, and Biocompatibility standards and requirements; (4) Experience with verification and validation requirements for single use disposable devices or reprocessed equipment; (5) Experience with requirements analysis, including development of testable and measurable specifications; (6) Experience working with cross-functional teams, working alongside R & D, Regulatory Affairs, Marketing and Manufacturing; (7) Experience with assessing written product and project documentation for compliance; (8) Experience with test method validation, root cause failure analysis, statistical methods, and design of experiment.