Helena Sowder
Research & Development Engineer at maruho medical- Claim this Profile
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Bio
Credentials
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SolidWorks Certified Professional
Dassault SystèmesApr, 2022- Oct, 2024 -
SolidWorks Certified Associate
Dassault SystèmesMar, 2022- Oct, 2024
Experience
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maruho medical
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Research & Development Engineer
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May 2023 - Present
• Responsible for the design of new implants and surgical instrumentation for sports medicine procedures • Responsible for the design of new implants and surgical instrumentation for sports medicine procedures
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DePuy Synthes
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United States
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Medical Device
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700 & Above Employee
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Associate Product Development Engineer
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Jul 2022 - Mar 2023
• Utilized 3D CAD software NX to design, model, and prototype surgical instruments for use in a novel approach to total shoulder arthroplasty • Executed Finite Element Analysis (FEA) using ANSYS to simulate the intra-operative and post-operative stresses of instrument use in bone • Collaborated with an international team of design surgeons in cadaver lab visits and interactive calls • Developed clinically relevant test methods and performed mechanical testing to evaluate new designs and establish performance criteria • Moderated and documented multiple usability labs with surgeons and used feedback to drive design changes • Created complex CAD layouts of shoulder anatomy and surgical instruments to create visuals for Surgical Technique Guide provided to surgeons • Performed total shoulder arthroplasty procedures in a cadaver lab to evaluate instrument performance and develop general surgery skills • Completed design control documentation including product map and Design Failure Mode and Effects Analysis (DFMEA) to identify risks • Modeled coupons for an INHANCE system animal study in collaboration with multiple manufacturing sites • Prepared analysis of INHANCE reverse shoulder system surgical technique complexity versus competitors for use in marketing materials • Early in Career panelist at WISTEM2D event advising college women on pursuing STEM careers and navigating their first job search Show less
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Hyalex Orthopaedics Inc.
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Medical Equipment Manufacturing
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1 - 100 Employee
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Product Development Intern
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Sep 2021 - Jan 2022
• Designed in SolidWorks, built, and tested motorized station to precisely trim excess polymer from implants of variable size • Performed Installation/Operational Qualification (IOQ) of trimming station, wrote work instructions, and trained future operators • Created initial designs and prototypes of cleanroom-safe device for unfurling and punching material that optimizes operator use • Wrote Excel Macro to automatically compare and report discrepancies between separate data exports • Inspected raw materials and surgical instruments against product specifications and as part of a supplier complaint investigation Show less
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Compliance Engineering Intern
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May 2021 - Jul 2021
• Reduced downtime at in-line weigh station by 41.6% overall and by 89.7% on the worst performing program through good run settings • Wrote work instructions to control weigh station program creation and changeover, standardized naming convention on all packaging lines, and removed 70+ outdated and duplicated programs following a deviation • Developed IOQ protocol for new filler component and updated On the Job training instructions and visual guide for assembly • Developed Preventative Maintenance schedules for packaging line electrical components Show less
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Alnylam Pharmaceuticals
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United States
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Biotechnology Research
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700 & Above Employee
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Manufacturing Validation Engineer Co-op
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Jul 2020 - Dec 2020
• Completed technical risk assessment of new shipping lanes for qualification for OXLUMO launch • Performed periodic review of closed deviations, CAPAs, and change controls as well as recorded shipment temperature data to maintain qualified status of established transportation lanes • Developed RASCI chart for all activities and deliverables across departments for Transportation, Process, and Packaging & Labeling Validation • Identified 100+ mislabeled or missing validation documents in Veeva Vault and coordinated with Document Control to correct them Show less
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Instron
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United States
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Industrial Machinery Manufacturing
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700 & Above Employee
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Applications Engineer Co-op
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Jul 2019 - Dec 2019
• Modeled in SolidWorks and 3D printed prototypes of test components for novel specimen geometries • Performed manual and automated tensile testing on a wide variety of material types to provide individualized recommendations to customers • Wrote and edited technical proposals for customers seeking automated testing solutions • Assisted during Factory Acceptance Testing at Instron manufacturing facility to train customers on safe operation and Bluehill method set-up • Modeled in SolidWorks and 3D printed prototypes of test components for novel specimen geometries • Performed manual and automated tensile testing on a wide variety of material types to provide individualized recommendations to customers • Wrote and edited technical proposals for customers seeking automated testing solutions • Assisted during Factory Acceptance Testing at Instron manufacturing facility to train customers on safe operation and Bluehill method set-up
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Macy's
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1 - 100 Employee
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Sales Associate
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Jun 2016 - Jun 2017
• Worked with customers to process purchases, returns, orders, and questions while managing dressing rooms and recovering sales floor • Worked with customers to process purchases, returns, orders, and questions while managing dressing rooms and recovering sales floor
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Education
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Northeastern University
Master of Science - MS, Mechanical Engineering, GPA: 3.92 -
Northeastern University
Bachelor of Science - BS, Mechanical Engineering, GPA: 3.87 | Summa Cum Laude -
W.T. Woodson High School
High School Diploma, GPA: 4.43 (weighted)