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Senior 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 Descriptionsurgical assistant, is looking for a seasoned manufacturing engineer to lead and manage release of new medical devices into production.DUTIES & RESPONSIBILITIESTakes ownership of activities for new product development during engineering design and pilot production stages to ensure a successful and sustained product launch.Proactively develops new product introduction plans and schedules. Escalates and resolves design, manufacturability, quality, and supply chain issues.Generates workflow process diagrams, manufacturing, and maintenance plans.Bears responsibility for development of detailed work instructions, procedures, checklists, travelers, and MPIs for new designs.Develops floor and line layout proposals for build capacity, quality, time optimization and effective inventory management.Participates in BOM management, technical specification reviews, new part requisition. Initiates Change Orders (CO) for release to production of various manufacturing documentation and supports document control in COs implementation.Complete process failure mode and analysis (PFMEA). Develops and validates critical tests used in production workflow to minimize risk.Responsible for the activities of validation and qualification of manufacturing equipment and processes utilizing standard qualification approaches (IQ/OQ/PQ). Manages development and delivery of completed validation plans, studies, and reports.Provides feedback for product and process DFM improvements to Engineering to ensure optimal manufacturability and serviceability.Responsible for maintaining compliance with medical device quality system requirements and FDA regulations.Provides technical support in analyzing and/or performing investigation for discrepant production components, assemblies, and field returns.Develops and updates procedures in order to consolidate new and existing product support.Participates in decision making for high dollar amount orders. Leads initiatives focused on cost reduction, effective vendor selection and management, outsourcing of subassemblies, etc.Visit, evaluate, and collaborate with vendors to ensure high quality & timely delivery of services.Assists with assembly, testing, and troubleshooting of electromechanical assemblies.Provides leadership, training, and technical support to production technicians.Implements fixtures to aid in production.Other duties or special projects as required in order to meet company's objectives.QualificationsRequired QualificationsMinimum a four-year degree (Bachelor's) in industrial or mechanical engineering or an equivalent combination of education and experience in medical devices with QSR/FDA ISO 13485:2016 or in a highly regulated manufacturing environment.Need a minimum of 5 years of experience in manufacturing engineering of complex electromechanical devices. Experience with IEC60601-1 compliant devices is preferred.Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.Experience with six sigma, 5S, GD&T is preferred.Experience using an ERP and PLM system, such as Epicor, Arena or similar.Strong technical skills in prototyping and troubleshooting using engineering documentation.Must be able to read and understand assembly drawings, BOMs, workflow diagrams, MPIs, identify components and read basic schematics.Possess skills and aptitude to lead projects, effectively manage multiple tasks in a timely manner, and coordinate work with others is highly desirable.Experience in writing, reading, and interpreting the documentation of designs and production processes. Able to define instructions that are moderately complex in nature.Good written and verbal communication skills with all levels of employees, suppliers, and customers.Preferred QualificationsKnowledgeable using SolidWorks 2017 or higher (assembly, sheet metal, 3D modeling and drawings) for fixture design work.Experience using Arena, Jira, Confluence, and Jama software in a collaborative environmentUnderstanding of tolerance stack upOSHA trainingCOMPETENCIESCreating effective production workflow and configuration management process for large medical device equipment and accessories.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 20%).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 , Senior Manufacturing Engineer, Other , Fremont, California

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