As a Manufacturing Engineer at Lexington Medical, you will be working on the development, implementation, and scaling of manufacturing processes for surgical devices, and oversee the transition of new products into production, including ensuring that the manufacturing processes meet regulatory compliance as well as quality and productivity objectives. In addition, you will be involved in the development of a global supply-chain as well as provide support for new product development and quality control.
We are looking for hands-on, data-driven, bright individuals who are interested in making a difference in a dynamic and exciting entrepreneurial environment. This is your opportunity to make a real difference in the lives of millions of patients worldwide.
Design, develop, and implement cost-effective, repeatable, and scalable manufacturing processes.
Define and implement process controls to ensure reliability and quality of products & processes.
Design workspace layout and assembly fixtures and source manufacturing process equipment.
Design, develop, and perform manufacturing process verification/validation testing.
Use statistical tools to optimize manufacturing processes for cost-reduction, quality, and efficiency improvements.
Support quality system development, implementation, and maintenance.
Support continuous improvement and CAPA projects, and product complaint investigations.
Ensure manufacturing processes are in conformance with ISO and FDA guidelines.
Document and maintain manufacturing process written instructions.
Provide training to production personnel on manufacturing processes.
Desired Skills and Experience
The ideal candidate will be a motivated individual looking to grow professionally in a fast-paced environment. Strong analytical skills, excellent knowledge of theoretical and practical fundamentals, and a solid ability to work on several projects simultaneously are required.
BS in Engineering (Mechanical, Industrial, and Operations engineering preferred), top tiered institution with excellent GPA.
Experience in the transition of new products into production
Experience in the design and implementation of manufacturing processes.
Experience in the medical device industry, or a similarly regulated industry.
Experience in ISO9001 and/or ISO13485 quality systems
Excellent working knowledge various production methods and 3D CAD tools (SolidWorks preferred)
Minimum of 4 years work experience. Exceptional candidates with less experience may be considered.
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.