Maggie Serra Email & Phone Number

Clinton, Massachusetts, United States

• Technical Lead for a combination product adhering to ISO 13485, 14971 and supporting with 62366-1 for aninjection-molded dry powder inhaler client project through DFMEA, DFM/DFA, Tooling Validations &.
• Managed client communication, led internal / external weekly meetings
• Maintained action tracker, risk register, and issue register, recording tasks, progress, and deadlines for… Show more
• Maintained action tracker, risk register, and issue register, recording tasks, progress, and deadlines for internal,client, and supplier operations
• Coordinated with a cross functional team made up of quality, regulatory, supply chain, and new productintroduction to achieve product milestones
• Worked alongside global team based in Bray, Ireland, including design handover at project phase conclusion

Waltham MA

• Design and SolidWorks modeling of injection molded parts, including Master Models, Surfacing, and otherspecialized modeling methodologies
• Generation of Technical Drawings following “good practice” around dimensioning and tolerance analysis
• Content Creation, Product Data Management and Control using PTC Windchill software
• Technical lead on consumer projects: Proof-of-Concept of smoking cessation device, self-extinguishing candle
• Technical lead on medical projects: DFM… Show more
• Technical lead on medical projects: DFM for Endoscopy Device, POC/DFM/Regulatory Maintenance for DryPowder Inhalers sold in both American and European markets

Clinton, MA

• Designed and Implemented new test equipment, GR&Rs
• Performed Customer Complaint investigations, interfacing with customers
• Writing/Support of documentation needed for regulatory compliance, audit management
• Generated and updated documentation around existing and new product lines

Clinton, MA

• Designed new products from ideation through final DFMEA
• Evaluated device prototypes with emphasis on design improvement
• Conducted test method development activities for new products
• Conducted user research with various clinical professionals
• Generated engineering protocols and reports
• Analyzed statistical data, presented results in the form of reports and recommendations

Worcester, MA

• Completed design, iterative development, and prototyping of the “ServoStock” 3D printer
• Decreased the number of required non 3D-printable parts, and standardized the remainder
• Made design changes that both saved on cost and improved accuracy
• Designed around scalability and parameterization
• Created a fully parametric library of reusable non 3D-printable modules
• Designed and manufactured 3D-printable replacement parts for machine tools

• Completed records and closed out job folders
• Created model of head loss in a manifold
• Assembled manuals
• Created parts list for fittings needed for a large scale projects

Bachelor'S Degree, Mechanical Engineering

Activities and Societies: WCPR (College Radio Station)

Master'S Degree, Mechanical Engineering

High School Diploma

Activities and Societies: FIRST Robotics, 4H, Technical Writing Mass Academy of Math and Science is a 2-year magnet school for gifted.