Lexington Medical 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 everchanging market conditions. Our recruiting philosophy is centered on attracting talented individuals committed to delivering innovation. Rooted in a talent dense culture that fosters continuous growth and achievement, both personal and organizationally, we've been organically scaling at a rapid pace and have aggressive hiring plans for the years ahead. By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company. We are seeking a Manufacturing Engineer to join our team. The ideal candidate will be solutions-oriented, working collaboratively with the production team to maintain the highest standards of quality in our manufacturing processes. This role focuses on continuous improvement and compliance with regulatory standards, ensuring our products meet the highest quality requirements.

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

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