Mechanical Engineer

Mechanical Engineer - Medical Device - Onsite - Boston, MA

My client is an innovative MedTech developing next-generation therapies for the treatment of glaucoma and corneal disorders. Due to continued growth across the US market, they are seeking an experienced Mechanical Engineer to join their collaborative engineering team. This is an exciting opportunity to work on cutting-edge medical devices while partnering cross functionally across hardware, quality engineering and manufacturing in a fast-paced, solution-oriented environment.

Responsibilities:

• Design, specify, prototype, document, procure, assemble, qualify, implement, and improve test equipment mechanical components and equipment.


• Work closely with engineering teams such as product development, test software, and process development to understand mechanical requirements, develop robust, reliable, and reproducible test and calibration equipment.


• Documentation to include generating equipment specifications, validation protocols, assembly instructions, preventative maintenance, and calibration (PMC) in addition to CAD component and assembly drawings.


• Analyze, debug and root cause measurement accuracy, reliability, repeatability, and reproducibility of equipment issues.


• Project manage equipment development projects that will involve coordination with manufacturing and software development teams.

Qualifications:

• BS or MS in Mechanical Engineering, Opto-Mechanical Engineering, Manufacturing Engineering, Mechatronics, or related area.


• 5+ years mechanical, equipment design engineering experience for medical devices.


• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and applicable quality system requirements.


• Design for manufacture and assembly (DFM/DFA).