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. Oversee Quality budget, coordinate budget planning process and track monthly spending. Manage yearly spending for the Quality team. Lead Design Assurance support for lifecycle management of Contract Manufactured and OEM product. Manage framework for CM and OEM DA support, including: Mentor and provide guidance to 1 P1 Design Assurance Engineer who supports CM and OEM product; Provide technical direction and cross functional support to Sr. Manager, Contract Manufacturing Quality and Sr. Manager, Global Distribution Quality; work collaboratively with corporate teams on Supplier Change Notifications and process improvements. 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 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. Collaborate with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies. Utilize expertise in Risk Management to drive procedural updates. Identifies specific action items, accountabilities, and timelines for completion of initiatives. Independently coordinate Health Risk Assessment team when needed for evaluation of on market product and 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. 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 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.