Manufacturing Systems Specialist

3 weeks ago


New Bedford, Massachusetts, United States Lexington Medical, Inc. Full time
Role Overview

Lexington Medical, Inc. is a medical device manufacturer in the Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market.

Our business structure enables us to produce a unique range of devices and proprietary technology best suited for leading surgeons and their patients, while also quickly adapting to the ever-changing market conditions.

We are seeking a Manufacturing Systems Engineer to join our team.

Key Responsibilities

* Develop and conduct process and equipment validation and verification activities, including risk assessments.

* Communicate with suppliers and contract assembly facilities to ensure a coherent product quality system.

* Construct a systematic approach to understanding outgoing product quality using sampling plans and non-destructive testing.

* Perform root cause analysis on quality issues and non-conformances, and implement corrective and preventive actions.

* Maintain accurate documentation related to quality activities, including inspection records, test results, and audit reports.

Requirements

* Bachelor's degree in Engineering

* 1-2+ years of experience in quality engineering within a manufacturing environment; medical device industry experience preferred.

* Sense of mechanical intuition and ability to quickly understand complex electro-mechanical systems.

* Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative, team-oriented environment.

* Strong organizational and project management skills, with attention to detail.

By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

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