If you thrive on working in a fast paced, exciting environment, and are ready to make a major difference within the organization, then you may excel at Lexington Medical.
The Process Engineer will provide technical expertise and support for daily manufacturing operations. Ensuring that production, quality and scrap yields are met, he/she will work with equipment and material vendors to improve the manufacturing process. This individual will perform Installation Qualification(IQ), Operational Qualification (OQ) and Performance Qualification (PQ) on new and existing product lines. The Process Engineer will work with cross-functional teams to provide solutions to manufacturing issues on the production floor. He / She will update manufacturing documentation, train operators and technicians on new and existing manufacturing processes. This individual will work independently on Corrective and Preventive Action (CAPA)and Nonconformance (NC) related to manufacturing issues. The Manufacturing Engineer will direct and plan engineering projects or studies.
Education and Experience:
Bachelor’s degree in Engineering, Mechanical, Electrical, Biomedical or a related science discipline is required.
A minimum of 3 years of manufacturing experience.
Proven experience in leading process improvement projects.
Medical device manufacturing environment preferred along with experience working within manual assembly environments.
Experience in workflow optimization, work measurement, efficiencies.
Recognized process improvement training (Lean, Six Sigma).
Strong communication skills and ability to communicate effectively with technical and on-technical staff.
Experience with planning and conducting tests to validate equipment and processes.
Experience in completing technical documentation for engineering and manufacturing.
Experience writing validations protocols such as IQ, OQ, and PQ is highly preferred.
Ability to work independently and effectively with cross functional teams. Thorough understanding of manufacturing processes.
Compensation and benefits:
Competitive base salary.
Highly attractive stock option package.
Opportunity to be part of an exceptional team of talented people.
Work authorization/visa plus relocation assistance for the right candidate.
About the Company
Lexington Medical is a Medical Device company established in 2013 by industry veterans. The company has developed a superior product targeting a multi-billion dollar market in minimally invasive surgery. The company has raised close to $30M to date from institutional investors, family offices and a Strategic partnership with one of largest Medical Device companies in the world. We are in our first full year of sales and are gaining very rapid adoption both in the US and internationally. The devices are manufactured internally at its Massachusetts facility.