Engineer - jr

US-NJ-Mahwah
2 months ago
Job ID
2017-27374
Category
Engineering
Position Type
Contract (Full-Time)
# of Openings
2

Overview

Carry out and lead validation activities for manufacturing processes, which include equipment qualifications, process qualifications, software validations, process capability studies, and process improvements. Understands and applies standard engineering principles. Support process development and design transfer activities, including, but not limited to, process mapping, operating procedures, inspection plans, MSA/gauge R&R studies, First Article Inspection, and training. Monitors quality of products and controls the efficiency of processes. Evaluates a design's overall effectiveness, cost, reliability, and safety.

Responsibilities

• Project manage the introduction of new capital equipment and support the associated qualification and validation activities.

• Work closely with the validation team to complete any validations required.

• Responsible for creating and managing engineering change request for the project.

• Facilitate manufacturing process changes including updates to inspection guidesheets, production routers, dynamic control plans (DCP), etc.

• Update operating procedures and applicable manufacturing documents as necessary.

• Work closely with quality engineering teams and operation cells in order to implement changes seamlessly.

Qualifications

• 2+ years in a manufacturing environment or similarly regulated industry. Medical device manufacturing preferred.

• Demonstrated problem-solving and troubleshooting skills.

• Demonstrated good interpersonal and written communication skills.

• Demonstrated results orientation, team skills, ability to multitask, ability to learn quickly, ability to respond to urgent needs of the team and deliver expected results within expected deadlines.

• Demonstrated ability to serve as a technical resource for assessing validation requirements and solving test related problems

• Demonstrated proficiency in standard office software, including Word, Excel, Project, and PowerPoint.

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