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Manufacturing Process Engineer

2 months ago

Mentor, Ohio, United States STERIS Full time

Job Title:
Manufacturing Process Engineer

Job Category:

Engineering

At STERIS, we are dedicated to assisting our Clients in fostering a healthier and safer environment by delivering cutting-edge healthcare and life science solutions globally.

Position Overview: The Manufacturing Process Engineer plays a crucial role in defining and upholding all manufacturing protocols and practices, which encompass capacity planning, tooling, process innovation, routing optimization, cost efficiency, and quality enhancement to support the Value Stream.

Key Responsibilities:

  • Drive ongoing improvement initiatives across manufacturing operations.
  • Establish, regulate, and enhance both new and existing manufacturing workflows.
  • Design fixtures and/or machinery to facilitate production, streamline processes, and enable the launch of new products.

Typical processes may involve assembly, injection molding, and fastening techniques (including pneumatic pressing, adhesive application, ultrasonic welding, resistance welding, and laser welding). Oversee the installation and validation of new and existing equipment, ensuring compliance with all necessary documentation in line with FDA and ISO regulations. Provide support for process control and troubleshooting.

Foster effective collaboration with various departments to optimize project management outcomes. Develop and maintain cost documentation for new products through direct labor standards and bill of material standard costs. Participate in and/or lead cross-functional teams to propel project advancements.

Additional Responsibilities:

  • Lead and execute cost reduction initiatives and capital equipment acquisition, including payback and capacity analysis, along with business case justification.
  • Maintain process documentation to ensure accuracy and availability at all times.
  • Submit change orders to update existing processes.

Assist in plant layout and ergonomic assessments to ensure efficient production while adhering to ISO and industry standards. Provide technical support and problem-solving expertise for production and facility challenges. Train production staff on new and revised processes. Collaborate with quality and operations teams to ensure compliance with ISO standards. Conduct Make versus Buy analyses for product components and tooling. A hands-on approach is essential, with a willingness to engage closely with all organizational levels. Most working hours will be spent in manufacturing environments. Additional duties or projects may be assigned as required.

Qualifications:

  • Bachelor of Science degree in an engineering discipline is required; relevant work experience may be considered in lieu of a degree.
  • Hands-on experience in a manufacturing environment.
  • Proficient in Microsoft Office Suite (Word, Excel, Access, & Outlook).
  • Familiarity with SolidWorks or similar CAD software.
  • Strong written and verbal communication skills are essential.
  • Experience in lean manufacturing is preferred.
  • Experience in medical device manufacturing is advantageous.
  • Experience in an ISO-certified manufacturing organization is preferred.

STERIS is a prominent global provider of products and services that enhance patient care, with a focus on infection prevention.

We are committed to helping our Clients create a healthier and safer world through innovative healthcare, life sciences, and dental products and services.