1492
Sr. Product Development Engineer   
Southern California - Catheters
Responsibilities include designing and developing least invasive surgery. This will include part design, material selection, detailed drawing, fabrication methods and vendor selection and coordination with an eye toward large scale manufacturing (i.e. molding stamping).  The design documentation will need to comply with governing standards including FDA guidance, Quality Systems Regulations, GMP and ISO.  BSME.  8 to 10 yrs. medical device exp.  Demonstrated proficiency in mechanical design, DFM, and specification development, preferred exp. in endoscopic or related device.

1500
Project Statistician   
Southern California - Clinical Research
Candidate must have SAS background.  Protocol writing, pharmaceutical and clinical research exp.  BS minimum.  5 yrs. exp. in statistics.

1503
Director of Regulatory Affairs    
Central Orange County - Catheters
Will define, coordinate, and prepare complex regulatory submissions (510(k), IDE, PMA, Design Dossier) and other documents necessary to obtain U.S. and foreign country approvals for company products.  Primarily responsible for interactions with the US FDA, EU Notified Body and other foreign regulatory agencies  BS in Science, Eng or related field.  10 yrs exp. managing Class II and Class III medical device regulatory programs.  Strong knowledge of U.S., EU, Canadian, Chinese, Japanese and other foreign country medical device approval requirements.

1505
Director, Clinical Evaluations 
Southern California - Oncology, Hematology, & Urology
Will provide strategic direction and lead the development and execution of clinical studies. Will provide clinical expertise to the R&D teams in the fields of oncology, urinalysis and hematology.  Ph.D. in Analytical Chemistry.  Exp. in FDA, ISO, QSR and GLP.  Clinical research in in-vitro diagnostic, biotechnology or pharmacology.

1506
Sr. Quality Engineer  
Southern California - Vascular
Collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launching of robust products. Responsible for Quality Engineering deliverables required within the product development program.  BS in Science, Engineering or related field. Working knowledge of GMP / QSR, ISO and Medical Device Directives.


1508
Director, Product Development 
Southern California - Oncology, Hematology, & Urology
Will lead the team of engineers and scientists in the design, development and validation of next generation urinalysis medical device. Ph.D. in a scientific or engineering discipline. Knowledge of Flow Cytometry and organic or dye chemistry is highly desirable.

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