This position is primarily responsible for exercising technical leadership and analytical skills in the resolution of production issues while keeping with Company goals and standards for quality and safety. Areas of responsibility include - implementing process improvements and manufacturing procedures including the conception, design and implementation of new tools and fixtures; preparation and execution of process validations; and, utilizing project management skills to assist in transitioning new products into production including fast-tracking incubator products.
Duties and Responsibilities
Owns all assembly and test procedures for Meters and related accessories from incoming inspection of purchased parts and sub-assemblies thru Final QC and shipment to Customers.
Responsible for the design, development and implementation of tools and fixtures required for the efficient and error-free assembly of meters and other assigned products.
Conceives, designs and directs the assembly of fixtures used in component, sub-assembly, meter and probe/sensor testing.
Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File.
Responsible for determining root cause(s) of failed components, sub-assemblies and completed meters and accessories and implementation of corrective measures with attention to impact on safety/ergonomics, quality, cost and production schedules.
Drives the effort to minimize product cost while maximizing product quality. Including effective collaboration with suppliers to meet these goals.
Develop and maintain Work Instruction / Direct Material / Router / BOM documentation and Cost Models for assigned products.
Be the champion of Lean Manufacturing and through direct observation of processing activities and the application of Lean principles, implement process /work flow improvements that decrease defects, reduce cycle time and /or reduce costs.
Define and execute validation plans for process improvements.
Present metrics for continuous improvement opportunities in safety, quality, customer service, throughput, productivity and cost.
Utilize SPC to monitor critical device performance parameters and establish meaningful process control limits to maximize yields.
Actively participate on new product release teams from the earliest phases to assure that design for manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing.
Support improvement projects by developing cost justifications and savings analysis.
Willingness to perform other work-related duties as requested, directed or assigned by management
Work cooperatively with Manufacturing leaders
Interact with all Company departments - Engineering, R&D, Production, Purchasing, QA, Regulatory, Marketing, Sales, Customer Service and Finance
Education and Experience
AAS in Electrical Engineering required.
BS in Electrical Engineering preferred.
Minimum of five years of experience. Preferred is prior experience in medical device industry and familiarity with FDA CGMP regulations.
Knowledge, Skills and Abilities
Solid understanding of PCB production, population and test methods, including use of AOI, Flying Probe and Bed of Nails.
Solid knowledge of CIRRIS testers.
Capable of developing a thorough understanding of the operating principles of a variety of proprietary circuit boards
Working knowledge of applicable FDA and ISO standards.
Knowledge and ability to utilize Solidworks for CAD modeling a plus.
Thorough understanding of engineering practices, product safety and root cause analysis.
Able to work with minimal direction towards completing project tasks.
Excellent analytical, troubleshooting and problem-solving skills. Capable of explaining the underlying concepts and principles.
Proficient in developing computer-driven test applications, preferably with LabView and/or Visual Basic.
Proficient in the use of project management tools and application of continuous process improvement methodologies such as Lean Six Sigma or equivalent. Prior success in the development and implementation of process improvement initiatives.
Excellent written and verbal communication skills including effective presentation of technical data to all levels within the organization.
Strong attention to details.
Excellent computer skills including MS Office and Microsoft Project
Requires understanding of validation concepts and document control.
Position primarily requires sitting, standing, talking and walking in an office environment includes use of computers, printers, copiers and other office equipment; stooping, climbing, standing, walking and talking in a manufacturing/production environment includes working with microscopes, oscilloscopes, testing equipment and tools
Nature of work requires depth perception, close and far vision, normal color distinction, potential for eyestrain and normal finger dexterity.
Ability to adhere to safety requirements
Corrected normal vision
Work environment includes office setting; production floor; machine shop; clean room; and test lab
Occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals
Travel is very minimal, domestic, and only as necessary
Disclaimer: This Job Description is not intended to be all-inclusive, and may be subject to change to include new responsibilities and tasks or change existing ones as management deems necessary to meet the ongoing needs of the company.
About this company
Transonic® offers employees the chance to make a difference. As a pioneering, high tech company, employees bring flow measurement benefits to: operating rooms where intraoperative flow measurements inform surgeons; research laboratories worldwide, setting the stage for medical advances; dialysis clinics where measurements enable proactive treatment to extend the lives of patients with kidney failure. In short, Transonic flow measurement technologies save lives.
Motivated employees enjoy an opportunity for both personal growth and professional advancement in a flexible, friendly, open, working environment. The company offers an excellent benefit package, including fully paid medical insurance, along with recognition for individual initiative and accomplishment.
Transonic’s headquarters is located in cosmopolitan Ithaca, NY, home to Cornell University and Ithaca College. Located in the unsurpassed beauty of the New York Finger Lakes region; in Ithaca, rural life and recreation interface with city sophistication and world class culture.
Location/Region: Ithaca, NY