Research and Development Engineer 2

Posting Date 3 months ago(6/29/2022 8:15 AM)
Requisition ID
2022-11012
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Inc - Bloomington
Category
Engineering

Overview

This engineering position, as part of a development team, will specialize in managing completion of design controls (design input requirements, traceability tables) and risk management documentation. Immediate areas of focus include drainage catheters, access sets and access sheaths as well as understanding clinical needs and how to translate needs into effective design solutions.

Responsibilities

• Specializes in creating design input requirements, traceability tables, and risk management documentation
• Collaborate cross-functionally (including with external design firms) to establish design input requirements, traceability tables, risk and hazard analyses.
• Work closely with physicians and other customers to develop design solutions for clinical problems
• Gather clinical application information, performance requirements and user needs; perform requirements and risk analyses.
• Provide constructive criticism and alternatives to design solution proposals for the betterment of design
• Create review and approve documentation related to design and transfer
• May act as project lead, coordinating cross-functional work and maintaining overall project plan

• Specializes in creating design input requirements, traceability tables, and risk management documentation
• Collaborate cross-functionally (including with external design firms) to establish design input requirements, traceability tables, risk and hazard analyses.
• Work closely with physicians and other customers to develop design solutions for clinical problems
• Gather clinical application information, performance requirements and user needs; perform requirements and risk analyses.
• Provide constructive criticism and alternatives to design solution proposals for the betterment of design
• Create review and approve documentation related to design and transfer
• May act as project lead, coordinating cross-functional work and maintaining overall project plan

Qualifications

• BS in Engineering or Engineering Technology;
• Minimum 3yrs, experience in Class II/III medical device manufacturing
• Experience using analytic skills and problem solving
• Extensive knowledge and application FDA 21CFR820, ISO 13485, ISO 14971

• Preferred experience with implementing ISO 13485 and ISO 14971 within the context of a development project and regulatory auditing methodologies.

 

Physical Requirements:

• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions

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