Process Development/Manufacturing Engineer

 

Corindus Inc. is a well funded, growing, early stage medical device company which has developed a unique robotic system to be used during percutaneous procedures in the cath lab. The company is establishing a new standard for the physician quality of life, workflow efficiency, and improved patient outcome in the fast growing $7.5B market. CorPathTM is a Class II system that delivers and controls cath lab devices during interventional catheterization procedures.  The development of the CorPath product is accelerating and therefore we have a need for a Process Development/Manufacturing Engineer.

 

POSITION SUMMARY:

The successful candidate will complete projects in the development of the product and be a major contributor to the transfer and support of the product in a manufacturing setting. 

 

The ideal candidate will have extensive knowledge of assembly of mechanical designs in plastic molded components and machined parts used in mechanisms as well as motors and control systems.  The candidate will be a hands on engineer and a strong participant in a cross functional team to complete the project.  A working knowledge of medical devices and Quality systems and the accompanying design controls is required.  An understanding of software in motor controls and validation is a big plus.  This is an ideal opportunity to join the team and make a real difference by using your experience and knowledge to shape the company’s products.

 

RESPONSIBILITIES:

1.      Participate in the completion of the initial product design.

2.      Develop and execute design verification and validation protocols and testing

3.      Lay out the manufacturing process and design transfer requirements

4.      Execute the design transfer into production including all testing and documentation required by the Quality system 

5.      Manage component vendor selection including mold qualification.

 

REQUIREMENTS:

1.      4-7 years in a process development or manufacturing engineering position preferably all in a medical device company.

2.      Full understanding of Quality system requirements and the production process including documentation in a Medical device company.

3.      Strong experience with electromechanical systems preferably in a robotic product.

4.      Previous success delivering products through commercialization

5.      Bachelors degree in a relevant discipline

6.      Software and its validation a big plus

7.      ProE or Solidworks proficiency

 

 

COMPENSATION:

A very competitive package including salary, bonus, and stock options to be scaled with respect to experience level.