Assist hardware R&D engineers and the Advanced Development team in conceiving, developing, prototyping, testing and debugging novel high-tech surgical robotics.

Assist hardware R&D engineers and the Advanced Development team in conceiving, developing, prototyping, testing and debugging novel high-tech surgical robotics.

Assisted scientists in testing structured materials for capacitive energy storage devices.• Performed quality control analyses to evaluate the quality and properties of raw materials, in-process formulations and new coating materials technology using analytical instruments such as HPLC, GPC, FTIR and TGA.• Responsible for organization and maintenance of one pilot scale laboratory. Stocked supplies, kept inventory records well organized and maintained accurate equipment logbooks. Ensured timely calibration and Preventive Maintenance (PM) of instruments with no safety and quality compliance violations and no project timeline delays.

Assisted engineers in developing, scaling-up and transferring new cutting-edge filling and packaging process equipment. Kept two pilot scale facilities organized and running efficiently while supporting scientists in early feasibility evaluation and development of new drug products and packaging materials.• Independently and quickly executed protocols to fill lactose blends and engineered particle bulk powders into blisters and capsules reducing the downstream idle testing time by 20%.• Performed process scale-up and optimization protocols, which resulted in successful transfer of filling and packaging technologies into clinical and commercial operations and achieved higher equipment efficiency.• Evaluated new manufacturing technologies and processes. Recommended design and procedural changes that led to improved safety and ergonomics for operators.

Assisted scientists in the manufacturing of CRISPRevolution products and the development of new processes. Assisted design and automation engineers in the development of new cutting-edge hardware.• Performed assembly and sub-assembly of components for new instrumentation in support of design and procedures improvement for more robust prototypes.• Prepared synthesizer reagents and accurately ran scientific protocols and analytical assays with complex robotic systems keeping production uninterrupted.

Actively contributed to the development of the Axxent® Electronic Brachytherapy (eBx™) System by executing Test Protocol Records (TPRs) for Design Verification Tests (DVTs) of different products and sub-assemblies.• Collected data to update Failure Mode and Effects Analyses (FMEAs) in regards to levels of occurrence, detection and risk mitigation. Provided meaningful input that led to improved product design and robustness.

Actively contributed to the product development, scale-up and production transfer of Advanced Lead Carriers (xLC™) from bench-scale laboratory prototype assembly to volume manufacturing.• Executed traveler-build records for manufacturing Advanced Antennas batches and operated High Volume Print Forming (HVPFTM) platform technology 3-D printing machinery for production of low cost, miniature complex structures containing multiple high-performance materials (ceramics, metals and polymers), reducing scrap by 23%.• Reviewed, simplified and improved Standard Operating Procedures (SOPs) for new equipment allowing operators to better understand process and follow instructions, which improved productivity and reduced recording time by 30%.

Executed Clinical Production Records (CPRs) in aseptic environment to manufacture Macroflux® transdermal microprojection array patch delivery system for parathyroid hormone (PTH) clinical trials.• Formed, coated, inspected and assembled microprojection arrays. Knowledgeable on the operation of all assembly fixtures. Provided daily production updates ensuring smooth and efficient transition of operations.

Executed Batch Production Records (BPRs) in Controlled Environment Rooms (CERs) to fill proprietary PulmoSphere and PulmoSol inhalation powders into aluminum foil blister packages or capsules with manual filling dosators. • Manufactured and packaged QAB149 (indacaterol) inhalation powder blisters for clinical trials achieving an increase of filling yield of 16%. Complimented for consistently exceeding standards for production and quality.

Supported planned returns of Zingo™ powder intradermal injection systems by executing investigation protocols and assisted engineers in the assembly and characterization of medical device prototypes and test articles.• Contributed to device technical transfer by providing training on device assembly and test processes to 6 new technicians at Contract Manufacturer (CM).• Performed inspection of incoming materials in support of Quality Assurance (QA) to ensure products met specifications, achieving zero defect level during secondary inspection.

R&D Engineering, Technician III:Provided hands-on support to R&D device engineers and scientists for Design Verification Tests (DVTs), Process Validation, Failure Mode and Effects Analyses (FMEAs) and Accelerated Patient Use Simulations for EXUBERA® (first insulin inhalation powder), second generation inhaled insulin and other pulmonary inhaler products.• Executed process optimization, qualification, validation and scale-up efforts including several product manufacturing transfers to Contract Manufacturers (CMs).• Executed planned returns and product complaints protocol investigations. Identified, investigated and troubleshot problems. Analyzed data and interpreted results. Assisted Engineering and Operations in determining root causes and implementing Corrective And Preventive Actions (CAPAs). Generated reports for Design History Files (DHFs).Device Manufacturing Lead | Floor Coordinator, Technician III:Led shift operations in clean room environment, supervising up to 8 junior technicians. • Interfaced with all cross-disciplinary support groups (QA, Supply Chain Management, Delivery Systems, Pharmaceutical Development). Participated in daily production scheduling, reported results and provided feedback to senior management. Improved prioritization and workload delegation processes increasing on time delivery performance to customers by 34%.• Participated in external audits, Quality Review Boards (QRBs) and technology transfers as a Subject Matter Expert (SME). Performed monthly internal quality and safety audits. Responded to audits and excursions by developing and implementing systemic improvements.Clinical Drug Manufacturing Technician:• Operated, assembled, troubleshot, maintained and cleaned manufacturing equipments to process and package fill aerosol powders in clean room environment. • Maintained calibration requirements of instruments up to date.

• Consulted by drafters and engineers regarding the impact of design changes to assembly and production.• Trained all new personnel on techniques and SOPs.• Read blueprints and built assemblies and sub-assemblies from drawings.• Assembled mainframe computers (300 mm and 200 mm cleaner), powered supplies, and installed modules.

• Built and tested main frame assemblies, sub-assemblies and harnesses. Routed and inter-connected wire and pneumatic harnesses. Soldered PC boards, built and tested canisters.• Demonstrated proficiency in color code system.

Materials Management Associate:• Stockroom associate and forklift driver.• Checked items to be received against purchase orders or invoices. Worked with Purchasing and created purchase orders. Initiated and maintained inventory control records.• Performed receiving and initial inspection for materials to ensure products met specifications. Participated in product investigations. Managed dispensing activities to support manufacturing schedules.Integration Mechanical Assembly Technician:• Built, installed and tested mainframe computers, sub-assemblies and power supplies. Routed harnesses.• Performed button-ups and touch-ups. Reworked systems to satisfy customers’ expectations.