Sr. Manufacturing Engineer 

         
Job Description:
The Sr. Manufacturing Engineer will be responsible for the development and to provide hands on interface with the implementation of process improvements to improve the device manufacturability and reliability.

Responsibilities:

  ·         Comply with this companies quality system requirements as well as any applicable regulatory requirements.

·         Develop and improve in-process test methods and test equipment. Implement changes in compliance with the quality systems, including document control and training, and in coordination with Quality and R&D functions.

·         Conduct FMEA, pre-validation studies, process validations, and equipment qualifications. Support efforts in validations related to processes and equipment in accordance with FDA and ISO guidelines. Generate clear and concise protocols and reports.

·         Develop and improve manufacturing processes in a manner consistent with zero defect levels and low production cost.

·         Support the “pilot” and production coordination of new products.

·         Supervise assigned technicians.  Responsible for guiding the technicians in assessment, data gathering and improvement processes.

·         Procure and interface with vendors and consultants as needed.

·         Maintain bill of materials, MPI’s, WI's, product drawings and general manufacturing documentation.

·         Trouble-shoot equipment and process issues. Support manufacturing requests and solicit manufacturing input on potential improvements. Lead weekly manufacturing meetings to track performance and issues.

·         Lead and/or support in the resolution of non-conformance and safety issues.

·         Contribute to the intellectual properties position of the company via invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.

·         Maintain current knowledge of competitive technologies and of medical, technical, and biomedical developments related to this companies products.

 
Education and/or Experience:   

 
§    BA / BS in manufacturing or engineering preferred.

§    Must have 5-8 years experience in manufacturing, including 2 years experience in medical device development and manufacturing, preferably with catheter or device based technologies. Other requirements include a strong knowledge of engineering fundamentals, ability to work independently, and demonstrated clear communication skills, both written and oral. Must have a proven knowledge of experimental design and the ability to apply this knowledge to product design and manufacturing. Must have a working understanding of GMP and ISO 9000.