Process Engineer I

Posting Date 3 weeks ago(11/3/2021 2:10 PM)
Requisition ID
2021-9796
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Engineering

Overview

The Process Engineer I at Cook Biotech, Inc. (CBI) is responsible for completing process improvement projects and work as defined in the sections below.
 

Responsibilities

• Lead complex process improvement projects and demonstrate mastery of error-proofing, root cause analysis, eliminating non value-added activities, and identifying/appropriately elevating process constraints

• Develop and implement advanced manufacturing solutions as agreed upon by key stakeholders

• Lead and contribute to risk analyses as needed to support regulatory requirements and quality system activities

• Lead and contribute to process validations and re-validations in a timely manner, and according to quality system requirements

• Qualify equipment, tools, and instruments (ETI)

• Facilitate continuous improvement of qualification processes

• Effectively and efficiently write specifications and instructions

• Effectively and efficiently generate technical drawings of ETI

• Procure or produce jigs and fixtures for projects as needed

• Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties

• Use, demonstrate competence with, and collaborate via continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen)

• Seek new skills/knowledge relevant to CBI

• Share relevant knowledge with other CBI employees.

• Propose solutions, decisions, and strategy

• Inform management of key decisions

• Facilitate collaboration of key stakeholders

• Listen to ideas from production, colleagues, and management

• Communicate effectively with production, colleagues, and management

• Provide training on process improvements

• Facilitate effective training of various groups on new methods/processes

• Relentlessly eliminate waste from processes by evolving the CBI quality system

• Facilitate continuous improvement of risk analysis process

• Facilitate continuous improvement of process validation system/processes

• Demonstrate mastery of writing and documenting activities in the medical device industry

• Demonstrate mastery of presenting information appropriate to the receiving audience

Qualifications

• Bachelor's degree in Engineering or related field, or equivalent experience
• Able to set goals for self and work to achieve milestones
• Able to work effectively on multiple projects simultaneously
• Able to understand and apply statistics
• Able to create and interpret technical drawings
• Able to efficiently operate CAD software such as Creo

• Able to efficiently operate statistical software such as JMP
• Able to effectively communicate with others
• Excellent record keeping and documentation skills
• Interest in working directly in a manufacturing environment
• Willing to work with material derived from animal tissues
• Sufficient background to generally understand medical and biotechnology terminology

 

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals and/or biohazards

• Physical demands are typical of an office environment.
• Willing to perform other corporate duties when required

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