experience.

Designed new medical devices, incorporating Design for Manufacturing (DFM) principles to ensure efficient production

Developed and implemented Engineering Change Orders (ECOs) and Deviation Request Forms in a quality-controlled system (ISO 13485) to create and modify parts, drawings, and work instructions, addressing product and process issues

Created a 510(k) application for regulatory approval of a new medical device

Oversaw production work orders, ensuring minimal risk to product specifications and compliance with regulatory requirements

Led design & construction of a production fixture that resolved long-standing issues, reduced scrap rates, & increased process efficiency.

Updated labels to comply with Medical Device Regulation (MDR) requirements, updated bill of materials (BOM)

Demonstrated proficiency in various manufacturing methods, such as laser welding, Swiss screw machines, laser ablation, etching, grinding, ultrasonic cleaning, insert molding, injection molding, cleanroom assembly, manual machining, and CNC

Utilized CAD software (SolidWorks) to design and develop mechanical components and systems for medical devices.

Conducted feasibility studies and prototype testing to validate fixture design concepts and capital equipment purchased

Collaborated with cross-functional teams (QC, QA, Machine Shop, Assembly, Molding) to define project requirements and specifications.

Designed and developed new products for manufacturing (DFM) with design review from concept ideas

Worked closely with Industrial Design to design new generation product requiring complex shapes (Surface Modeling)

Designed and rapidly prototyped (FDM 3D printed) models & Instron test fixtures using CAD systems (SolidWorks PDM)

Exposed to injection molding (2 shot, insert), die casting, and profile extrusion

Authored engineering test methods to evaluate product specifications and capabilities through Instron tensile testing

Inspected and measured complex parts using contactless multisensor (vision and laser) system (Optical Gaging Products)

Programmed metrology system via ZONE3 software to inspect and measure parts

Conducted lab testing such as environmental (corrosion) and drop testing to simulate real-world consumer usage

I teach and tutor undergraduate Mechanical Engineering courses such as Statics and Thermodynamics.

I utilize problem-based learning (PBL) to demonstrate the physics of these courses with real world problems.

I have interest in strengthening the physical understandings of rising engineering students to better our future's field of engineers.

Performed design verification testing for FDA premarket approval on a medical device

Designed, tested, and documented test fixtures for test repeatability and reproducibility (process validation of standard test methods)

Completed notebook studies comparing performance of controlled parts vs modified parts

Revised documents in a quality-controlled system (ISO 13485 and 21 CFR 820 QSR regulated environment)

Introduced and calibrated equipment

Interdisciplinary communication across departments (R&D, Quality, Manufacturing, Operations, Purchasing, and Leadership) 

Reverse engineered and fabricated (CNC) parts critical for the functionality of  manufacturing machines and created SolidWorks drawings

Designed assembly fixtures to promote process improvement, consistency, and operator efficiency (Six Sigma)

Performed time studies to gauge accurate assembly line metrics and ultimately create Standard Work Charts to reflect operator efficiency

Created process validation reports to modify an existing process and reduce scrap and increase operator efficiency (Lean Manufacturing)

Interdisciplinary communication with other departments such as quality, product development engineering, purchasing, sales, and safety

Designed a lock mechanism to prevent rotation of a clamp around a chromatography column during shipment

Developed a buffer cart designed to hold several 50 liter IV while accommodating a work shelf and storage

Assisted in a transfer of parts and drawings from Solidworks PDM Workgroup to Solidworks PDM Standard

Developed a spring-loaded slave cylinder to prevent air leaks through the O-Rings of chromatography columns

Greeted and checked in club members and guests

Handled and distributed sales inquiries to sales department

Assisted members with billing inquiries

Supervised front end department employees with task assignment and timing of breaks

Resolved customers' issues regarding price adjustments and refunds

Escalated appropriate complaints to management

Cash swept, cash dropped, and counted tills daily

Reconciled net sales on the store's balance sheet