Maggie Serra Email & Phone Number

Sterling, Ma, Us

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 & EngineeringVerification testing, and ending in successful handoff at Design Validation Stage• Managed client communication, led internal / external weekly meetings• Maintained action tracker, risk register, and issue register, recording tasks, progress, and deadlines for… Show more • 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 & EngineeringVerification testing, and ending in successful handoff at Design Validation Stage• Managed client communication, led internal / external weekly meetings• 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• Based on Moldflow reports, proposed and implemented CAD updates to greatly improve molding performance• Drawing generation based on Design for Inspection methodology, coordinating with tooling team and customerto select inspection dimensions appropriate to process and representative of part function• Collaborated with assembly teams and vendors to develop and revise relevant specifications• Failure mode investigations and design improvements• Scratch-built 3D 145 element Tolerance Analysis in Design Control Power software package• Vendor Engagement for Injection-Molded and Thermoformed parts• Mentoring and Training of Contractors and Junior Employees• Continuation of Machine Shop maintenance and General Engineering Team Meeting Show less

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 • 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 for Endoscopy Device, POC/DFM/Regulatory Maintenance for DryPowder Inhalers sold in both American and European markets• Measurement method development and fixture design for in-process assembly checks• Design for Manufacturability (parting line, wall thickness, draft analysis) of Injection Molded parts• Design for Assembly (integration with electronics and other components, consideration for assembly process)• Interpretation, reporting, and acceptance of supplier data for FAI, Process Capability (IQ, OQ, PQ)• Headed Machine Shop, in charge of all tool maintenance, safety procedures, training, and equipment• Ran weekly knowledge-sharing Engineering Meetings for internal team• Took initiative to create macros and job automation tools saving in excess of 40 engineering hours per year Show less

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• Prepared documentation in support of Design Verification/Validation, Regulatory… Show more • 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• Prepared documentation in support of Design Verification/Validation, Regulatory Submissions• Developed CAD models and technical drawings• Supported company safety improvements (e.g. GEMBA walks, Job Safety Analyses, etc)• Developed automatic visual measurement programs using OGP• Interfaced with subject matter experts in fields of injection molding, high-volume assembly automation, and material science Show less

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• Created a library of modules… Show more • 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• Created a library of modules using script-based CAD software, now taught as “good practice” Show less

• 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.