David Roell Email & Phone Number

Irvine, CA, US

Irvine, California, United States

Lake Forest, California, United States

• Managed a team of 6 engineers responsible for providing comprehensive support across all facets of Applied's Laparoscopic Voyant Intelligent Energy System product line which produces 1.5MM to 2MM parts annually
• Oversaw completion of tooling repairs and validations, troubleshooting of manufacturing issues, and spearheading initiatives aimed at enhancing product performance and quality
• Reviewed and provided feedback on all documents routed within the Enterprise Resource Planning (ERP) system to ensure compliance with Standard Operating Procedures (SOPs) and the internal Quality Management System (QMS)
• Leveraged expertise and collaborated with a cross-functional team to implement Master Validation documents to streamline the manufacturing qualification process while adhering to ISO 9001 principles
• Communicated with customers to provide insight on the capabilities of the manufacturing processes and collaborated on resolutions to ensure products meet all specifications
• Maintained oversight of scrap costs utilizing PowerBi analytics to identify manufacturing deficiencies (> 5% scrap, <90-95% yield) based on internally established Key Performance Indicators (KPIs) and kicked-off.

Lake Forest, California, United States

• Debugged manufacturing processes and equipment issues through comprehensive root cause analysis and implemented improvements to prevent future occurrences
• Supervised large-scale cost savings projects ($2MM annually) in collaboration with multiple departments to meet market implementation dates
• Created and maintained technical documents, such as manufacturing instructions, graphical aids, test methods, and component drawings
• Authored and reviewed protocols and reports designed to thoroughly document the validation process (IQ, OQ, PQ)
• Advised product-specific teams on the manufacturability of components and areas of potential improvement to achieve a higher level of component quality
• Worked in a vertically integrated advanced manufacturing facility that included processes such as polymer and liquid injection molding, insert molding, metal injection molding, heat treatment, and automated equipment

Rancho Santa Margarita, California, United States

• Managed the qualification process for over 40 unique components to be injection molded and metal injection molded (MIM) for a proposed 510 (k) medical device
• Directed decisions pertaining to material selection, colorant choices, formulation considerations, and delivered constructive feedback regarding Design for Manufacturing (DFM) principles to Research & Development teams
• Created and maintained a comprehensive technical documentation catalog for each component, encompassing critical elements such as material masters, bill of materials (BOMs), manufacturing routers, sign-off sheets.
• Researched, sourced, tested, and analyzed a diverse array of material compositions and grades with the aim of optimizing the performance of components and the assembled devices
• Conducted benchtop testing and assisted in porcine laboratory experiments to comprehensively evaluate device performance

Rancho Santa Margarita, California, United States

• Provided support to Applied’s Kii Access System (15MM parts annually) through Non-Conformance Investigation Reports (NCIRs) and Customer Experience Reports (CERs) employing methodologies such as 5 Whys and Fishbone.
• Led redesign and new component prototyping projects aimed at enhancing the efficacy of existing product lines
• Formulated cost analyses on proposed new molds, meticulously assessing factors such as cavitation, machine selection, and return on investment to inform strategic decision-making
• Engaged in cross-functional collaboration with the Engineering, Production, Quality Control, Regulatory Affairs, Research & Development, and Tool Design teams to facilitate the seamless integration of innovative.
• Managed a comprehensive material replacement initiative for Applied's flagship product line, encompassing an extensive evaluation of more than 20 prospective material candidates with expected cost savings of $100k

Brea, CA

• Authored supplier validation technical documents and assisted with injection molding Design of Experiments (DOEs)
• Traveled to supplier sites to observe validation activities and part production to monitor accuracy and timeliness
• Prototyped new component and tooling ideas to better understand feasibility prior to implementation
• Formulated Requests for Quotation (RFQs) and maintained interaction with suppliers to ensure parts were produced according to company specifications
• Coordinated project specific activities of a multi-discipline team and served as the single point of contact until project closure
• Reinforced computer-aided design (CAD) skills by recreating and refining existing products and fixtures in SolidWorks

Oakland, PA

• Investigated the ability to create a rebuildable filler structure through the use of ternary systems
• Generated new concept sketches and designs for a small scale polymer mixer
• Performed the tasks of mixing samples, collecting and evaluating data, and analyzing microscopic images
• Gained a comprehensive understanding of the materials used as well as the equipment needed to complete experiments
• Reinforced solid communication skills through weekly meetings and numerous presentations to superiors

Bethel Park, PA

• Maintained standards in sales area and stock shelves to ensure customer requirements are met
• Built customer loyalty by providing unparalleled customer service
• Assisted in maintaining back room efficiency by unloading deliveries
• Rotated and checked code dates on products to ensure customer's safety
• Reinforced good communication and interpersonal skills, problem solving, numeric computation/ reporting, and adaptability

Bachelor Of Science (B.S.), Plastics Engineering Technology

Activities and Societies: New Student Orientation, Society of Plastics Engineers Member

High School Diploma

Located in Bethel Park, Pennsylvania.