•Design an A.I. powered cancer screening instrument using Solidworks, including sheetmetal support structure and plastic exterior panels. •Develop beta concepts for management review.•Work closely with the electrical team to layout all electrical components and circuit boards.•Create drawings for mechanical and electrical components.•Responsible for mechanical requirements and specifications.•Collaborate with vendors on mechanical and electrical components including design and analysis.•Benchtop testing of instrument components and subsystems to verify design intent.•Lead DFMEA and Hazard Analysis meetings with software, mechanical, electrical and software teams.•Comply with IEC-60601 to ensure mechanical and electrical safety.•Create Bill of Materials.•Deploy alpha units to clinical sites for testing.

•Design vascular access products such as peripheral and central catheters using Solidworks. •Benchmark competitor products to determine competitive product specifications. •Assist in Design of Experiments to determine product specifications. •Update drawings and products to the latest ISO-80369-7 Standard to meet upcoming US and EU regulations. •Participate in laboratory testing working in conjunction with the laboratory technicians. •Write design verification plans and testing reports. •Analyze and present data using Minitab and statistical methods. •Operate the 3D printer lab and print prototypes for the department.•Mentor junior engineers.

•Collaborate with R&D Engineering to design, develop, analyze, troubleshoot processes and provide t technical support during new product development, quality improvement, and sustaining operations.•Develop best practices, routines, and process documentation and operating instructions.•Manage and/or participate on cross functional teams to accomplish project specific goals.•Present technical findings or project status to cross functional teams through meeting minutes, design reviews, presentations •Support the qualification of new parts/materials, and machine validation through FAI/capability analysis.•Preparation of Capital Appropriation Requests.•Create, release and manage Bill of Materials and routers in ERP system.•Special projects as needed to support operations and our customers.•Maintain a thorough knowledge of new developments and technology.

•Early phase development activities for projects, working closely with the Project Manager to develop accurate technical tasks for the project plan.•Plan, schedule, conduct and coordinate detailed phases of engineering work in projects of technical/design scope.•Perform design reviews and pre-validation assessments to ensure safe and sound start-up of new design/technical recommendations.•Planning and execution of design reviews throughout the development cycle of the device, ensuring customer requirements are met.•Responsible for process development, sourcing & supply chain, prototype builds, verification testing, process qualification and transfer into manufacturing.•Work with sales to review and evaluate new opportunities.•Write and update work instructions, part specifications, validation protocols and technical documents.•Mentor junior level engineers.

•Lead design engineer responsible for designing new projects and supporting existing product lines.•Create models and drawings using Solidworks CAD package.•Fabricate sheetmetal panels and brackets in 316L Stainless Steel or Aluminum 6061.•Design plastic parts taking into account draft angles, parting lines, pull directions, sink marks, boss design and material specification.•Order and build SLA assemblies to verify form, fit and design language.•Generate Piping and Instrumentation Diagrams.•Apply Geometric Dimensioning and Tolerancing to all drawings.•Create Bill of Materials using ERP systems for new product lines.•Facilitate Engineering Change Orders/Notices from initial entry to completion.•Communicate and visit suppliers to discuss design elements to reduce manufacturing costs.•Assist in writing mechanical and software test protocols.•Participate in Alpha and Beta testing on new products.•Responsible for calibration of tools and gauges used in testing.•Represent the engineering group in manufacturing task force meetings to resolve production issues.•Collaborate with the Quality, Operations, R&D and Marketing teams to meet company goals.

•Collaborate with Research and Development as well as Application Engineers to meet customers' business needs.•Create drawings for customers' parts, tools, and fixtures using SolidWorks.•Review Engineering Change Notices including signing off on drawings, bills of materials, and work instructions.•Assist Quality Assurance with Defective Materials, Return Merchandise Authorizations and Corrective Action Requests.•Write and validate work procedures for existing and new products.•Validate and document fixtures and tools before releasing to production floor.•Familiar with various thermoplastics including PEEK, FEP, PTFE, and PFA.•Use of lathe, milling and grinding machines to create fixtures and tools for the production floor.

•Provided on-site support to our clients, which included laboratories, hospitals, and research institutions. •Repaired the Ikoniscope, an automated diagnostic medical device, including soldering components, replacing subcomponents, swapping PC boards and calibrating to original specifications.•Familiar with electromechanical components including servos, step motors, piezoelectric motors, springs, and actuators. •Utilized volt meters and oscilloscopes to ensure proper electrical calibration on various components.•Networked Ikoniscope to work with customer’s workstations, intranet, or internet. •Assisted in streamlining production process and setting quality control systems.•Completed documentation, including Device History Records, according to FDA, GMP/GLP and ISO13485 guidelines.•Conducted functional testing and data analysis on instruments.•Write manufacturing and field procedures to improve work flow.