Manufacturing Engineer

Company: THINK Surgical, Inc.
Location: Fremont
Posted on: May 3, 2021

Job Description:

47201 Lakeview Blvd, Fremont, CA 94538, USAFull-timeCompany DescriptionTHINK Surgical, Inc., a privately held U.S.-based medical device and technology company, develops, manufactures and markets active robotics for knee replacement surgery. The TSolution One Total Knee Application performs automated preparation of the bone and joint surface and supports a versatile, open platform providing surgeons the flexibility of using a variety of implants. The TSolution One Total Knee Application system is comprised of TPLAN, the 3D pre-surgical planning workstation, and TCAT, the active robot that helps the surgeon execute each patient's individual preoperative plan with consistent results. These evolutionary technologies are advancing total joint replacement surgery.The TSolution One core technology has been used in thousands of successful total joint replacements for both hip and knee worldwide. The TSolution One Total Knee Application was FDA cleared in October 2019. THINK's second-generation TSolution One Total Knee Application received FDA clearance in November 2020, and is commercially available in the United States.Job DescriptionThe Manufacturing Engineer shall engage in continuous improvement activities to achieve high product performance and quality. Shall create or modify technical documentation, such as component specification, drawing, traveler, manufacturing instructions, and test procedures for electro-mechanical components and sub-assemblies; implement cost reductions; develop assembly and test fixtures to aid in production of a surgical robot; conduct root cause investigations of non-conforming materials, provide troubleshooting assistance, rework, and disposition instructions. Provide leadership in the PFMEA, Verification & Validation (V&V) activities, and engineering pilot build activities. Manufacturing Engineer is required to follow all their functions while maintaining compliance to Food & Drug Administration (FDA) Quality System (QSR's) and international Organization of Standards (ISO) 13485:2003.DUTIES & RESPONSIBILITIESSupports assembly, testing, and troubleshooting of electro-mechanical assemblies.Develops and updates manufacturing process instructions, travelers, checklists, procedures, and other required production documentation.Develops and updates fixtures and test procedures for electro-mechanical components, subassemblies, and the final product.Escalates and resolves design, manufacturability, quality, and supply chain issues.Provides feedback for product and process DFM improvements to Engineering.Creates and maintains workflow process diagrams and manufacturing plans.Responsible for activities related to development or update of a PFMEA.Provides leadership in protocol development, setup, and execution of the V&V activities.Record and analyze test results, and prepare accurate, grammatically correct, and complete reports.Initiates Change Orders (CO) for release to production of various documents.Represents Engineering in the Material Review Board meetings and assist with the disposition and root cause investigation of non-conforming materials.Participates in complaints investigations and closure, as needed.Handles multiple tasks, under the timely requirement.Effectively collaborates with Engineering, Production, Supply Chain, Doc Control, Service teams.Other duties or special projects as required in order to meet company's objectivesQualificationsRequired QualificationsPrefer four-year degree (Bachelor's or technical certification) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2003 or in a highly regulated manufacturing environment.Need a minimum of three years of experience in manufacturing engineering of complex electromechanical devices. Experience with IEC60601-1 compliant devices is preferred.Basic knowledge of electronic components (PCBA, cables, DC motors, etc.).Experience using Solidworks 2015+ or equivalent CAD platform.Have the ability to define instructions that are moderately complex in nature.Must be able to read, understand, and update assembly prints, parts list, wiring diagrams and wiring lists. Can identify components and read schematics.Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.Attendance, Punctuality, and Motivation to succeed in a fast-paced environment are important function of the position.Preferred QualificationsAble to create or modify 3D models & drawings using ANSI Y14.5 in Solidworks 2015+Experience using Enterprise Resource Planning system (Epicor is preferred) and PLM platform (Arena is preferred).Experience with six sigma, 5S, and understanding of GD&T.Understanding and experience in setting up product configurations management.COMPETENCIESAchieves results as defined by the program or department manager.Optimizes production processes based on product knowledge and high decision quality.Effective collaboration with Manufacturing personnelDemonstrates initiative with good time management skills.PHYSICAL DEMANDS & WORK ENVIRONMENTMust be able to remain in a stationary position and operate office equipment for a prolonged period of time.Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 30 lbs.Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.Occasionally work around moving electro-mechanical parts.Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.Must be able to travel as business necessitates (up to 10%).Additional InformationTHINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow's leading orthopedic solutions today, we would love to hear from you.THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.47201 Lakeview Blvd, Fremont, CA 94538, USASDL2017

Keywords: THINK Surgical, Inc., Fremont , Manufacturing Engineer, Other , Fremont, California