Development Engineer II

Requisition ID 2023-12071
Posting Date 1 month ago(1/3/2023 10:32 AM)
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Engineering

Overview

The Development Engineer II at Cook Biotech Inc. has responsibility for completing the required activities intended to advance CBI technology platforms and product designs that meet clinical needs and customer requirements. Primary areas of responsibility include Design Feasibility Activities, Process Development Activities, Design Control and Risk Management Activities, Design Verification/Validation Activities, Bench Testing, and constructing Design History Files and Risk Management Files in accordance with Quality System Documents.

 

Responsibilities

Areas of Responsibility
• Executes sub-projects related to the primary functional areas listed above
Technical Knowledge 
• Demonstrates knowledge of experimental design and experience performing laboratory and feasibility activities
• Demonstrates knowledge of Cook Biotech Quality Systems
• Demonstrates experience in applying ISO 13485 and ISO 14971 principles for executing job responsibilities
• Able to identify and apply external standards to job responsibilities
Decision Making
• Uses experience and judgement to recommend path forward
• Consults with senior team members and supervisor for decisions as needed

Collaboration
• Works with the local team and has become established as a collaborator with other functional areas
Change/Innovation
• Identities and records improvement opportunities
• Identifies improvement opportunities within the Quality System
• Submits change orders for Quality System improvements
• Submits invention disclosures with other team members

Qualifications

• Master's degree in Biomedical Engineering, Chemical Engineering, or related scientific field, or, a Bachelor's degree with applicable experience
• Ability to design and execute experiments intended to support feasibility and development efforts
• Good documentation skills with the ability to appropriately record complex laboratory activities
• Able to write laboratory protocols and reports, as well as perform data analysis
• Experience with application of statistical methods (t-test, ANOVA, confidence limits, tolerance intervals)
• Familiar with lab equipment, manufacturing equipment, and manufacturing processes common for biomaterial processing

• Good task and time management skills with the ability to work on multiple projects simultaneously
• Project management skills; able to effectively communicate task status and project updates to team member, management, and other stakeholders
• Able to receive and appropriately act upon ideas, suggestions, and feedback from peers, managers, and other stakeholders
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology
• Able to work both independently and as a member of a team depending on the needs of the project

 

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations

• Limited exposure to hazardous chemicals or biohazards
• May work in a Biosafety Level II lab

• Physical demands are typical of an office and classroom environment
• Willing to conduct other corporate duties as required

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed