Grace Hynes Email and Phone Number

- Execute risk management and design control documentation for traditional and special 510(k) submissions- Compose annual and quarterly analysis reports, summarizing if any product or process trends are present- Responsible for construction and upkeep of device master records (DMRs) for all divisional products- Develop product inspection criteria for newly-released devices and associated instrumentation- Manage the creation and maintenance of vendor evaluations for the division - Initiate and manage divisional CAPAs, NCMRs, and deviations- Led the successful remediation of design history files (DHFs) for eight product systems simultaneously in response to FDA feedback, ensuring compliance with regulatory standards- Participate in validation labs alongside product development team and design consultants

- Interpreted hydraulic schematics and utilized PTC Creo to design custom manifolds- Primary technical liaison to applications and sales teams regarding European product line- Created STEP models and technical drawings for international and domestic prototypes- Executed to date over 150 revisions to 500+ models and assembly drawings via engineering change orders- Participated in monthly meeting with North American engineering, sales, and supply chain teams to identify the causes of low-margin products and determine solutions to increase profits- Member of the Material Review Board, which met daily to determine the proper disposition (use as is, rework in-house, or send back to supplier) of nonconforming products- Assembled and hydraulically tested valves to verify product catalog data curves- Communicated with international counterparts to supplement access to technical materials- Consulted with on-site production floor personnel on assembly and testing procedures- Travelled to company's European facilities in Switzerland and Italy to meet with international colleagues and receive training on in-house manufacturing processes- Received hands-on training for hydraulic system troubleshooting, project management, and root cause analysis

- Led redesign of shop floor production cells to improve cell flow, sequence standard work, and include the integration of pick-to-light systems- Utilized Autodesk Inventor to design and implement new tools to be used in production cells for testing and/or assembly- Updated and created process sheets, sequence standard work, and PFMEAs- Conducted time studies to identify areas of waste and improve production rates

- Conducted tests in the Security & Signaling Department, specializing in the Initiating & Indicating Devices division- Measured device compliance to UL standards in the audibility, smoke detection, and strobe laboratories - Conducted tests alongside respected clients- Won company-wide competition to rename the corporate internship program "Make Your Mark"

- Provided technical and clerical support for the client services department- Assisted with onboarding of new media clients

- Provided care and supervision for elementary and middle school children- Effectively communicated with parents regarding their child's progress- Organized games and crafts, taught science experiments, and encouraged safe practices