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Senior Manufacturing Process Engineer

Viant Medical
South Plainfield, NJ Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 3/23/2025
General Description

We are seeking a highly skilled Injection Molding and Automation Process Engineer to lead and optimize manufacturing processes for injection molding, assembly, and automation systems. This role requires extensive experience in validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), and the ability to implement and troubleshoot automated manufacturing solutions. The successful candidate will ensure that all systems and processes meet stringent quality, regulatory, and production efficiency standards.

Responsibilities

  • Maintain safe work practices.
  • "Hands-on" technical support for operations and operators to facilitate knowledge multiplication, problem resolution, standard work, and best practices
  • Provide Scientific Molding Analysis by identifying optimal conditions by evaluating factors such as material temperature, flow rate, pressure, and cooling rate during molding process and most important during the development of molding process.
  • Lead the creation and execution of IQ, OQ, and PQ protocols and reports for injection molding, assembly, and automation equipment.
  • Analyze validation data to confirm that processes meet regulatory and customer requirements.
  • Develop validation documentation and lead activities of Process Technicians in support of assigned projects and new product introductions.
  • Design, implement, and optimize automation solutions for manufacturing, including vision systems, robotic systems, assembly lines, and automated inspection equipment.
  • Manage the scrap reduction program and oversee the daily implementation and monitoring of the EDart system.
  • Collaborate with team members to troubleshoot molding machine issues and conduct Non-Conformance Report (NCR) investigations as needed.
  • Develop and implement new fixtures, manufacturing processes, techniques, process improvements and cost reductions.
  • Perform data analysis and/or write progress reports on existing manufacturing processes to ensure performance is within expectations.
  • Troubleshoot and maintain automated systems to ensure continuous production flow and minimize downtime.
  • Lead the integration of automated equipment into existing production systems while ensuring compatibility and compliance with safety and regulatory requirements.
  • Partner with cross-functional teams to drive innovation in automation and manufacturing technologies.
  • Supports new process implementation and current production process improvement / optimization.
  • Monitors assembly operations, tracking efficiency and potential issues where assigned.
  • Identifying and analyzing of flows, layout, and workplaces.
  • Root cause analysis of failure modes, solving equipment and process issues.
  • Manages project timelines. Contributes to project budgets.
  • Perform other duties as assigned

Requirements

  • 5 years’ experience in a medium/high volume manufacturing environment (injection molding, assembly, etc.)
  • Knowledge of statistical techniques (design of experiments, measurement R&R, and statistical process control).
  • Working knowledge of machining, tools, fixturing, and assembly practices.
  • Knowledge and experience of subassembly and assembly operations of plastic molded and metal parts
  • Knowledge and working experience with mechanical (indicators, micrometers, etc.) and electronic metrology instrumentation (CMM, Interferometer, Confocal microscope, etc.) is preferred.
  • Excellent interpersonal and verbal/written communication skills.
  • Advanced PC skills with standard MS Office software.
  • Knowledge and experience in secondary processes, i.e. ultrasonic welding, UV curing, pad printing, laser printing preferred
  • Knowledge and experience of manufacturing engineering in medical device industry preferred

Education

  • Bachelor’s degree in engineering required
    • Mechanical or Manufacturing Engineering preferred
Physical Requirements

  • Some of the work is performed in a typical office environment and includes long periods of sitting as 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 machine operation
    • Using measurement devices
    • Assembly or fabrication of parts at distance close to the eyes
  • This position requires less than 10% travel
Conditions And Environment

Some of the 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 chemical

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

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.

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