Manufacturing Engineer

DESCRIPTION

The Manufacturing Engineer is responsible for providing technical, hands-on knowledge and support for all aspects of production operations. Under the direction of the Operations Manager, the Manufacturing Engineer will be a tool owner and process owner and will be responsible for the development, implementation, setup, monitoring, and adjustments for the efficient operations of molds, machines, and auxiliary equipment. The Manufacturing Engineer is responsible for providing training, guidance, and coaching for technicians and operators. The Manufacturing Engineer will analyze operations to identify opportunities and implement changes to maintain and improve process yields as well as providing cross-functional support for process improvement projects, quality, productivity, cost reduction, and other exercises.

RESPONSIBILITIES

  • Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and standard operating procedures (SOPs) as defined by Viant’s policies and procedures
  • Represent Engineering in signing on Change Orders
  • Manage all engineer responsibilities for assigned manufacturing changes and/or new product launches
  • Design and develop new molds, processes, process improvements, and cost reductions
  • Develop, run, and document operational qualifications
  • Monitor, recommend, obtain management approval, and implement improvements to fixtures, tools, methods, and processes to meet productivity and specification standards, including researching and providing cost estimates for design or process changes
  • Evaluate existing machinery and processes; recommend improvements to improve operator safety/work ergonomics
  • Optimize layout and material flow and implement lean concepts in work cells to increase manufacturing efficiencies, takt time, floor space utilization, and overhead
  • Develop or review and revise technical documentation of manufacturing processes, include documentation of equipment qualification(s), setup, and maintenance procedures
  • Respond to/troubleshoot issues and repair machinery; arrange for repair if unable to resolve issue
  • Research, test, validate, and document compliance with quality standards, conformance to engineering designs, and overall safety of all manufacturing processes
  • Use lean manufacturing root cause analysis/problem solving methods to identify opportunities for cost, lead time, inventory, and defect reductions
  • Provide training to new or updated manufacturing processes
  • Perform other duties as needed

REQUIREMENTS

  • 3+ years of engineering work experience or equivalent experience
  • Experience in contract manufacturing and/or manufacturing environment preferred but not required
  • Experience working in a regulated environment (ISO 13485, 21 CFR 820, or other) preferred but not required
  • Injection molding experience preferred but not required
  • Advanced computer capabilities including Microsoft Office software
  • Strong interpersonal, written, and oral communication skills
  • Well organized and able to multi-task, prioritize, and manage multiple deliverables while working in a fast-pace environment
  • Problem-solving skills and critical thinking
  • Highly motivated, focused, self-starter
  • Quality-driven customer service
  • Able to work individually and as part of a team
  • Knowledge of statistical techniques (design of experiments, measurement R&R, statistical process control) preferred but not required
  • Working knowledge of machining, tools, fixturing, and assembly practices preferred but not required
  • Knowledge and working experience with mechanical (indicators, micrometers, etc.) and electronic metrology equipment (CMM, SmartScope, etc.) preferred but not required

EDUCATION

  • Bachelor’s degree in engineering or equivalent experience; mechanical or manufacturing engineering preferred but not required

PHYSICAL REQUIREMENTS

  • Some of the work is performed in a typical office environment and includes long periods of sitting at a desk, computer use, and frequent use of hands
  • This position does require moderate amounts of walking, standing, bending, kneeling, stooping, pushing, pulling, reaching, lifting, and twisting
  • Employee may be required to exert up to 50 pounds of force occasionally, and/or up to 20 pounds frequently, and/or up to 10 pounds of force constantly to move objects
  • Worker is required to have close visual acuity to perform activities such as:
    • Preparing and analyzing data and figures
    • Transcribing
    • Viewing a computer screen
    • Extensive reading
    • Visual inspection involving small defects, small parts, and/or operating machines
    • Using measurement devices
    • Assembly or fabrication of parts at distance close to the eyes
  • Some travel may be required

CONDITIONS

Some of the Manufacturing Engineer’s responsibilities and duties are performed on the production floor and/or in the warehouse of a manufacturing plant that can be hot in summer, cold in winter, hazardous, noisy, and dusty. The worker may be subject to:

  • Inside environmental conditions: Protection from weather conditions but not necessarily from temperature change
  • Noise: Sufficient noise to cause a worker to shout in order to be heard above ambient noise
  • Vibration: Exposure to oscillating movements of the extremities or whole body
  • Hazards: A variety of physical conditions such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat, or exposure to chemicals

Position location: South Plainsfield, NJ

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.