As a Senior Manufacturing Engineer at Lexington Medical, you will be responsible for 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 repeatable, scalable, and cost-effective manufacturing processes.
- Design workspace layout, source manufacturing process equipment, and lead IQ, OQ, PQ.
- Define and implement process controls to ensure reliability and quality of products & processes.
- Design, develop, and perform manufacturing process verification/validation testing.
- Document and maintain manufacturing process written instructions.
- Apply DFX and statistical tools to enhance product design and optimize manufacturing processes.
- Support continuous improvement and CAPA projects, and product complaint investigations.
- Support supply-chain development, including qualifying new suppliers and resolving supplier issues.
- Support quality system development, implementation, and maintenance.
- Ensure manufacturing processes are in conformance with quality and regulatory requirements.
- Coach and develop junior engineers and train assembly and test technicians.
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, Biomedical, Industrial, and Operations engineering preferred), top tiered institution with excellent GPA.
- Demonstrated track record of successful project leadership and execution.
- Experience in new product introduction (NPI).
- Experience in the design, development, and implementation of assembly processes.
- Experience in the medical device industry, or a similarly regulated industry.
- Experience in ISO9001 and/or ISO13485 quality systems
- Excellent working knowledge of various production methods and 3D CAD tools (SolidWorks preferred)
- Strong team orientation and ability to lead in a cross-functional environment
- 5~10 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.
About the Company
Lexington Medical, a venture-backed company founded by a seasoned team with a proven track record, is designing new surgical devices to address one of the largest unmet needs in medical devices. We are extremely selective in our hiring and employ a small team of super-talented individuals whose aim is to have a major impact. This is your opportunity to make a real difference in the lives of millions of patients worldwide.