Medical Device Disposable Products Manufacturing Engineer

 iScience Surgical, Inc., founded in 2000, is a medical device company focused on the development and commercialization of high frequency ultrasound imaging systems and microsurgical instruments for ophthalmic surgery.  Through the use of high resolution imaging technology and novel microsurgical instruments, the Company will enable surgeons to precisely locate and access comprised ocular structures in a wide range of surgical procedures.

 

iScience Surgical is seeking a full time Disposable Products Manufacturing Engineer to report to the SR VP of Operations.

 

Candidate must have knowledge and experience with FDA's QSR's and ISO 13485.

 

RESPONSIBILITIES:  The manufacturing engineer will be responsible for supporting the micro-catheter manufacturing production process in a clean room environment by improving processes, yield and efficiency.  The engineer is also responsible for supporting other disposable medical products and processes either in house or at vendors.  Participate in the development and execution of IQ, OQ and PQ and other validation activities.  Release of process documentation for new processes and training of production personnel.  Ability to resolve manufacturing process issues.  Hands on equipment/fixture prototyping, development and implementation.  Participate in FMEA's and other risk assessment documentation.  Optimize processes for yield improvements, cycle time improvements and scrap reductions.  Work with vendors and suppliers for transfer of new products into manufacturing.  Provide manufacturing engineering expertise to Purchasing, Quality and R&D Departments during vendor qualifications and evaluations.

 

Qualifications:

BS degree in an engineering discipline or equivalent.  6-8 years of working experience, including 3-5 years of successful medical device experience.  Familiar with injection molding, extrusion and sterilization processes.  Start-up Company experience desirable.  Strong leadership skills demonstrated ability to drive cross-functional inititative with limited supervision - self starter.  Ability to handle multiple tasks concurrently.  Strong written and verbal communication skills.  Good interpersonal skills.  Must be a "hands-on" individual with a proven track record of resolving materials, process, equipment, or training issues on production floor efficiently.  Ability to plan and implement projects from concept to completion.  A good understanding of electro-mechanical devices and their applications.  Working knowledge of FDA QSR's and ISO 13485.

 

We offer a competitive salary, medical, dental, life insurance along with 401(k) program.

 

Please email resume to

elamm@isciencesurgical.com

Or fax to ATTN:  Human Resources

Fax Number 650-421-2783

No phone calls please.