Sustaining Engineer

Posting Date 1 month ago(8/18/2021 5:35 PM)
Requisition ID
2021-8931
Job Location(s)
Vandergrift PA United States
Travel
Less than 10%
Shift Type
First
Position Type
Full Time
Company
Cook Vandergrift
Category
Engineering

Overview

The Sustaining Engineer at Cook Vandergrift will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.

Responsibilities

- Interface with Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians as necessary to progress projects/tasks.
- Manage multiple project timeliness, resources and responsibilities to achieve team, departmental, and company goals.
- Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
- Follow Design Control and risk management procedures and comply with requirements of 21CFR820 Quality System Regulations and ISO 13485 as applicable.
- May supervise / coach technicians or other engineering employees.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

- Must work and interact effectively with others throughout various levels of the organization
- Must strictly adhere to safety requirements
-Must maintain regular and punctual attendance
-Must maintain comply 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

Qualifications

• Bachelors Degree in Biomedical or Mechanical Engineering or equivalent 
• Previous project management experience preferred
• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
• Proficient in Microsoft Word/Excel/Outlook

 

Physical Requirements:

• Works under general office environment conditions
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to sit, stand, walk, and communicate

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