Talent.com
Sr. Global Sustaining Engineer
Sr. Global Sustaining EngineerCook Group • Bloomington, IN, US
Sr. Global Sustaining Engineer

Sr. Global Sustaining Engineer

Cook Group • Bloomington, IN, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Overview

Senior Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product / process remediation, risk analysis, regulatory approval support, and product / process improvements. The Senior Engineer works independently with limited supervision on complex activities and projects. The Senior Engineer acts as a mentor and leader in the department and may review / approve the work of less experienced engineers and / or contractors. This is a Global Sustaining Engineering position.

Responsibilities

  • Lead discussions within team / department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects / tasks.
  • Efficiently manages multiple project / task timelines, resources and responsibilities to achieve team, departmental, and company goals.
  • Identify and escalate problems / obstacles and identifies possible solutions to team lead / manager for discussion and resolution. Works with other team members to provide problem-solving guidance. Utilize critical thinking and past experiences strategically to inform project / task decisions.
  • Presents project / task status updates clearly to team members and team lead / manager. May also present to functional directors / executives as necessary.
  • Provide guidance and assistance to technicians or newer engineering employees / co-ops / interns / contractors. Reviews and approves outputs as necessary.
  • Demonstrates advanced design and risk knowledge of relevant product lines including process and regulatory details.
  • Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate.
  • Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
  • Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
  • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
  • Must strictly adhere to safety requirements.
  • Maintain regular and punctual attendance.
  • Must maintain company quality and quantity standards.
  • Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
  • Ability to remain calm and receptive in fast paced situations.

Qualifications

  • Minimum 5 years engineering experience in a regulated industry, preferably in a medical manufacturing environment. Advanced degrees may reduce the experience requirement by 1-2 years. Project management experience preferred.
  • Bachelor's degree in Engineering.
  • Familiarity with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
  • Experience in communication and working with a wide variety of associates.
  • Experience working independently and directing others towards a common goal.
  • Proficient in Microsoft Word / Excel / Project / Outlook, JBase, Engineering Server, Business Objects.

    • Physical Requirements :

  • Works under general office environment conditions.
  • Utilizes close visual acuity for working with computers and equipment.
  • Frequently required to sit for extended periods of time, stand, walk, and communicate.
  • Personal protective equipment including safety glasses, lab coat and gloves may be required in some areas associated with this position.
  • Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA

    • J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Sustaining Engineer • Bloomington, IN, US