Medical Device Mechanical Design

Dan La Rochelle

Santa Rosa, CA ***** 707-***-**** *********@***.***

MECHANICAL, PROCESS & AUTOMATION QUALIFICATIONS

Mechanical design, design upgrades and redesign. Design review, verification and qualification

Experience ranges in plug/mold/Fairings design and vacuum layups in fiberglass, Kevlar & carbon fibers. Epoxy & polyester resins. Sterilization & Matl treatment Autoclave experience

Well-developed range of understanding in GD&T, tolerance analysis and Metrology

Team-oriented, and cross-functional experience with a hands-on approach

Self-starter w/ proven track record of improvements in productivity, quality and profitability

Strong Mfg. situational analysis, statistical process control and automation implementation

Good ability in writing methods, ECOs & test plans with emphasis in mechanical systems

TECHNICAL QUALIFICATIONS

Computer-aided drafting using AutoCAD 2016 & all previous, Solidworks, Pro-Engineer

MATLAB, Minitab & SPC analytical methods development. Automation problem-solving

Over 3 years of experience with cGMP engineering documents in biotech/pharmaceutical

System-level design, commission & support in SCADA, process equipment & instrumentation

Clean Room experience, facilities operations and training in cGMP certification

Validation of Clean-In-Place (CIP) & Steam-In-Place (SIP) for process vessel & transfer lines

Experience in change control scoped modifications of Validated and Non-Validated processes

Data collection instrumentation, PLC control systems & analytical instruments for lean mfg

Ladder logic, Labview & automation systems programming and implementation

Allen Bradley HW/SW with PLC5, SLC500, ControlLogix, RSLogix500 & 5000, DeviceNet

Experience with HVAC Driers to 1400 F & PTFE bonders, various industrial machinery & upright Mills, Arc & MIG welders, etc. Plasma arc Argon/Nitrogen Titanium furnace use.

EMPLOYMENT HISTORY

P & L Specialties, Santa Rosa, Ca

Machinery weld/assembly & General Shop Operations 12/2021 –

Machine operation, grape Harvest Delivery Systems, De-stemmers, Processing Mechanical Equipment troubleshooting. Perform mechanical systems upgrade review mtgs. Electrical Schematics/drawing sets reading. Associated Systems & electrical panel builds Project/contractor/team markups and CAD changes

CBRE (Viavi/OCLI site), Santa Rosa, Ca 04/2018 – 2020 (COVID-19)

Mechanical Processing Analysis & Drafting: Facilities Maintenance HVAC/ DI/ CA/ N2/ PCW

Listed processing supply systems maint & upgrade installs, Schematics redlinees & Plan View/ layouts redlining with supporting drawing sets. Convert multiple legacy Hand & CAD drawings. Multi-drawing links. CAD standards input for drafting team. Work within and beyond peer master drawing sets. Mfg. Floor Space Planning, Cleanroom lab experience. Facilities experience.

Santa Rosa Junior College, Santa Rosa, Ca 04/2013 - Present

Archive / Library Technician —Library Periodicals & Archive departments. Perform general photo/lithography archive & retrieval. Periodical process, display & archive of all publications. General management of Inter-Library Loans department, new accounts, shipping & receiving. Daily use of Voyager, OCLC WorldShare and frequently MS Office & Access

Medtronic, Santa Rosa, Ca 12/2011 - 03/2012

Process Development and Research Engineer — Manufacture Abdominal Aortic Aneurysm & Renal stent grafts and delivery systems (Catheters). Select catheter & packaging materials for trials & validations. Oversee manual-to-automation efforts for bonding equipment with Allen Bradley ControlLogix PLC. Refine stent-graft manufacture and bonding processes. Equipment Lead in PLC programming efforts. Test stent-graft for transfer. Nitinol stent / ePTFE graft machinery and medical device design of experiment (DOE) efforts/data collection using Minitab.

Commissioning Agents – Genentech Site, Vacaville, Ca 04/2009 - 08/2010

Process Equipment Commissioning Engineer —Process equipment PLC & instrument changeouts, re-validation, testing, certify & document under IQ/OQ/PQ & FAT/SAT validation protocols. Complete training in 21 CFR Part 210 & 211, Title 21. Establish good engineering and good manufacturing practices (GEP & cGMP). Manufacturing process HVAC and label apply system upgrades with validation constraints.

Integrated Biosystems, Napa, Ca 11/2007 - 08/2008

Manufacturing/Automation Engineer — Customize standardized glycol based Freeze/Thaw refrigeration units for compounds separation. Manage and integrate specific customer needs to Standard HVAC unit. Instrumentation interfaces, vessel commissioning and operation customization. Develop, revise & finalize unit specific SOPs. Carryout Process equipment IQ/OQ, FAT/SAT & cGMP testing. Technical vendor point-of-contact support. Technical liaison for Customer inquiries from initial refrigeration/HVAC needs assessment thru final acceptance.

Brooks Automation, Petaluma, Ca 08/2006 - 06/2007

Mechanical Design Engineer — Design modifications, upgrades & HVAC compressor changeout adaptations to Refrigeration units for R12 phaseout of end-user silicon wafer vacuum systems. High voltage electrical control system component selection, panel designs & integration. Development of critical path product line efforts. PC and PLC5 based systems design thru production line implementation. HVAC Compressor unit sizing. Use of Ematrix MRP systems. AutoCAD Mechanical 3D model conversions to ProEngineer 2001. Identify & implement 3D model redesigns/upgrades. Mechanical inspection with frequent GD&T review for new designs. As-built red-lining and updates.

General Dynamics Versatron subdivision, Healdsburg, Ca This division develops control

actuator sub-assemblies for military and aerospace missile applications with contributions to Army Extended Range Guided Munitions and Beal Aerospace vehicles as well as full discretionary direction of Excalibur Munition testing and qualification development.

Internal R&D Project Lead Engineer Participate as part of dynamic, multi-disciplinary team of electrical engineering, software engineering, mechanical engineering, and technician support towards completion of contract goals. Perform mechanical and test fixture component design. Perform materials engineering & test analysis. Integrate vendor support and contract employee deliverables. Participate in project resource allocation and company-wide man-loading projections. Review component selection and trade evaluations. Direct R&D efforts for equipment redesigns. Test hardware design, selection, procurement, and implementation.

Systems Simulation Engineer Perform system simulation and optimization studies on actuator sub-assembly control including time domain and frequency domain analysis, open loop step response analysis, closed loop steady state analysis, Nyquist stabilities to predict system performance. Plant controller schemes include lead-lag/lag-lead and PID control on analog and digital systems. Controller tuning optimizations (Zigler-Nichols, IAE, ITAE, Cohen-Coon, etc.) Simulation within MATLAB using customized code implementation.

EDUCATION AND CERTIFICATIONS

Santa Rosa Junior College, Santa Rosa, CA 01/2013 - 12/2017

Geospatial Information Systems (GIS) Certification

Civil Engineering Technician Certification

Sustainable Agriculture Certification

Chico State University, Chico, CA 09/1988 - 05/1991

Degree earned, BSME (BS Degree in Mechanical Engineering)

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