Sustaining Engineer II

2 weeks ago

Spencer, United States Cook Medical Full time
Job Title: Sustaining Engineer IICompany: Cook Medical

The Sustaining Engineer II will be responsible for activities associated with the upkeep of commercially available medical devices. This role includes tasks such as product and process improvements, risk evaluations, support for regulatory compliance, and enhancements to existing products and processes. The Sustaining Engineer II typically works independently while receiving general guidance from their supervisor or mentor on complex projects.

Key Responsibilities
  • Engage collaboratively with team members and other departments (including Production Engineering, Product Management, Regulatory Affairs, Clinical, Quality Engineering, Quality Assurance, Operations, external vendors, and healthcare professionals) as necessary to drive projects forward.
  • Manage multiple project timelines, resources, and responsibilities to achieve departmental and organizational goals.
  • Identify and escalate challenges or barriers, proposing viable solutions for discussion and resolution with the supervisor or mentor. Utilize analytical skills and prior experiences to inform project decisions.
  • Provide updates on project progress to team members and management, and may present to other departmental leaders as required.
  • Mentor and support junior engineers, technicians, interns, and contractors, and may evaluate and approve their work outputs.
  • Exhibit comprehensive knowledge of product lines, including practical design and risk management.
  • Comply with Risk Management protocols and adhere to ISO 14971 standards as applicable.
  • Follow Design Control processes and ensure compliance with 21CFR820 Quality System Regulations and ISO 13485 standards as applicable.
  • Fulfill all training requirements for the position and actively pursue opportunities for professional growth and advancement.
Qualifications

A Bachelor's degree in Engineering or a related field, along with a minimum of three years of relevant experience. Advanced degrees may reduce the experience requirement by one to two years.

  • Demonstrated experience in project management.
  • Knowledge of statistical methods related to sample sizes, confidence intervals, capability, risk assessment, and proven problem-solving skills.
  • Proficiency in Microsoft Office Suite (Word, Excel, Project, Outlook), JBase, Engineering Server, and Business Objects.

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