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Manufacturing Engineer II

2 months ago

Southington, Ohio, United States ICU Medical Full time

Position Overview

The Manufacturing Engineer II will play a crucial role in supporting the Research and Development sector of ICU Medical. This position is tasked with the creation and execution of innovative products while adhering to established design control protocols and sound engineering practices. A primary focus will be on enhancing and refining ICU's product offerings to guarantee their effectiveness and dependability. The engineer will engage extensively with materials such as plastics, polymers, and molding processes, particularly in the realm of medical disposables and solid modeling. This role necessitates collaboration with both internal stakeholders and external suppliers regarding the design and configuration of high-volume disposable medical devices. Additionally, the engineer will assist in navigating the development and compliance complexities associated with new medical products, requiring interaction with various functional teams including Marketing, Regulatory, Quality, and Operations.

Key Responsibilities

  • Facilitate the product development lifecycle from initial concept through to production.
  • Define product specifications in alignment with customer requirements and business objectives, ensuring compliance with relevant international standards and regulations.
  • Follow established design control methodologies and uphold best engineering practices.
  • Utilize SolidWorks to design and model components and devices across diverse product lines.
  • Assess parts, products, or processes for their efficiency and reliability to secure the long-term success of new or enhanced product lines.
  • Provide technical guidance on components, materials, methods, systems, and equipment.
  • Establish the technical basis for the development of risk management documentation.
  • Create testing protocols to confirm adherence to specifications and regulatory requirements.
  • Author, review, and endorse protocols, reports, and data documentation.
  • Execute testing as outlined in established protocols and methodologies.
  • Conduct engineering and validation studies on products.
  • Perform investigations into product failures.
  • Participate in special projects as assigned.

Required Knowledge & Skills

  • Exceptional attention to detail with the ability to manage extensive workloads and data.
  • Strong interpersonal skills, particularly in verbal and written communication, customer service, time management, professionalism, coaching, influencing, and team collaboration.
  • Familiarity with medical device manufacturing standards.
  • Understanding of medical-grade plastics and general principles of injection molding.
  • Proficient knowledge of plastic joining techniques.
  • Experience with design of experiments (DOE) and fundamental statistical methods.
  • Proven project leadership skills with the ability to drive project completion.
  • Competency in SolidWorks is essential.
  • Comprehension of engineering mechanics and physics principles.
  • Awareness of machine shop practices.
  • Knowledge of drafting standards.

Minimum Qualifications, Education & Experience

  • Must be at least 18 years of age.
  • Bachelor’s degree in Mechanical Engineering or a related discipline from an accredited institution; a Master’s degree is preferred.
  • 2-4 years of experience in the development of medical devices.

Work Environment

This role is primarily sedentary and operates within a professional office setting, utilizing standard office equipment. Travel requirements are minimal, typically less than 5% of the time.

Salary Range

The anticipated salary range for this position is between $72,000 and $96,750 annually. This range reflects the base salary we expect to offer for this role, though actual compensation may vary based on factors such as relevant experience, skills, education, and geographic location.