Product Support Engineer 2

2 weeks ago


Spencer, United States Cook Medical Full time
Job Title: Product Support Engineer 2Company: Cook Medical

The Product Support Engineer 2 will be responsible for activities associated with the upkeep of commercially available medical devices. This role includes tasks such as product/process improvement, risk evaluation, support for regulatory compliance, and enhancements to existing products and processes. The Product Support Engineer 2 typically works independently with general guidance from their supervisor or mentor on complex tasks and projects.

Key Responsibilities
  • Engage collaboratively within the team and across various departments (including Production Engineering, Product Management, Regulatory Affairs, Clinical, Quality Engineering, Quality Assurance, Operations, and external vendors) as necessary to progress projects and tasks.
  • Manage multiple project timelines, resources, and responsibilities to achieve departmental and organizational goals.
  • Identify and escalate challenges or barriers, proposing potential solutions for discussion and resolution with the team lead or mentor. Utilize analytical thinking and prior experiences to inform project decisions.
  • Provide updates on project progress to team members and leadership, and may also present findings to other functional leaders as required.
  • Mentor and support technicians or less experienced engineering staff, including co-ops, interns, and contractors. May evaluate and approve work produced by junior engineers or contractors.
  • Exhibit comprehensive knowledge of design and risk management relevant to specific product lines.
  • Comply with Risk Management protocols and adhere to ISO 14971 standards as applicable.
  • Follow Design Control protocols and maintain 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, coupled with a minimum of 3 years of relevant experience. Advanced degrees may allow for a reduction in the experience requirement by 1-2 years.

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


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