Mark Stauder Email & Phone Number

Irvine, Ca

Project Lead Engineer. Responsible for Design History File documentation and scheduling, as well as management of two mechanical and two electrical engineers. Development of a handpiece and console used for ENT surgery.

Laguna Hills, Ca

Project Lead Engineer. Designed products for Endodontics console using SolidWorks.Created solid models, detail drawings and assembly drawings.Created 3D printed prototypes.

Device Lead Engineer. Drove generation of Design Control and Risk Management documentation for Ophthalmic implant drug delivery system.Produced component and assembly drawings. Worked with R&D and Quality in Combo Products Division on device product development. Represented functional group in various cross-functional teams.Responsible for Design History File (DHF) and generated deliverables.Worked with vendors and resolved documentation issues.

Covina, Ca

Hosted astronomy and cosmology presentations and studies pertaining to the age, origin, and fine tuning of the universe.Provided sales support for scientific books and DVDs authored by organization’s astronomer, astrophysicist, and biochemist.

Yorba Linda, Ca

Led projects and completed Change Control documentation, Device Master Records, Regulatory Assessments and Project Lead memos.Produced injection molded prototype parts within a week. Utilized SolidWorks 3D modeling & Direct Metal Laser Sintering (DMLS) technology to 3D print metal prototype molds.Designed extruded corrugated tubing and three new ISO compliant 15mm/22mm connectors for consumable breathing circuits.Wrote OQ & PQ protocols and reports for plastic part mold changes and material changes.Led contract manufacturer end of life mold replacement.Utilized project management tools Outlook, MS Word, Excel, Project & PowerPoint.Key Competencies:• Mechanical Engineering• Medical Devices• Injection Molding• Project Management• Product Development• R & D

Lake Forest, Ca

Reduced cost of Fluidics Module Level Sensors by $250,000/yr. Released all engineering documentation to production. Completed Engineering Change Plan, Risk Based Assessments, Verification Protocol, Mfg Test Procedures and R&D Verification tests.Completed Project Management of an obsoleted LCD Display. Redesigned sheet metal & plastic mounting. Released all engineering documentation. Completed all Verification tests.Provided design and development support for Vitrectomy R&D team and manufacturing department. Included product & process functional improvements, product design/redesign (using ProE), analysis, and cost savings throughout beta and pre-production builds.Developed CNC machining operations for large die casted aluminum Base and managed vendor/supplier change of tooling.Updated packaging for Laser Probes, Illumination Probes and Infusion Cannulas. Completed ISTA 2A Consumable Packaging Integrity Testing –Trans, Environ, Thermal, etc. Completed EtO Sterilization, Real Time and Accelerated Aging.Completed layout and relocation of three production lines, including workflows & cycle times.Completed development of consumable illuminated laser probe; protocols, reports, V&V testing.Completed functional improvement of RFID Laser Probes. Design update added RFID capabilities to eleven new probes. These Probes (20 Ga, 23 Ga, & 25 Ga) included illumination and aspiration. Project involved two new injection molded parts, a new RFID tag, assembly fixtures, test fixture, new tray, new carton, new dividers, new labels.Managed RoHS compliance project through implementation of Chem Film per MIL-DTL-5541 Type II, Class 3, Clear, on sheet metal & eliminated use of hexavalent chromium. Developed & implemented means of measuring electrical resistance at less than 5000 micro ohms/sq in at an electrode pressure of 200 psi.Additional duties included mechanical engineering, medical devices, injection molding, project management, product development and R & D.

Completed introductions of new prescriptions of aesthetic sapphire orthodontic braces. Designed, developed & released new brace prescriptions. Completed Clinical Trials.Improved fit and patient comfort. Increased ceramic brace strength by 80%. Doubled sales from $7 million to $14 million in 4 years. Reduced annealing time by 38%. Reduced tumbling cycle by 27%. Chaired weekly meetings. Established project timelines. Wrote test procedures and protocols. Presented project to management. Made component purchase decisions. Determined project cost and schedule. Interfaced with Manufacturing, Quality, Regulatory Affairs, Planning, Marketing and Sales departments.Additional duties included mechanical engineering, medical devices, injection molding, project management, product development and R & D.Completed a Clinical Study which optimized the debonding forces of ceramic orthodontic braces.