Kuhn Med-Tech

CURRENT JOB LISTINGS
(Last updated 08/15/2008)


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Kuhn Med-Tech is currently recruiting for these and other positions

 Research & Development Mechanical

 Quality / Regulatory / Clinical Affairs 

 Manufacturing / Operations

Research & Development Electronics / Software  

Management

Sales & Marketing

Research & Development - Mechanical

1472
R&D Engineer  
Bay Area - Endovascular devices.
Will manage the development of new and improved products, components, and processes per the product plan.  Manage technical personnel involved in developing new and improved products and manufacturing processes. Will manage outside vendors and contractors providing products or services to the company.  M.S. or B.S. in Engineering or equivalent exp. with 5 or more years progressive exp.  Medical device development preferred. Knowledge of GMP and Quality System Standards. 

1477
R&D Engineer  
Southern California - Ophthalmic products.
IOL or contact lenses exp.  Must have CNC Program exp. Hands-on; concept to pilot run. Solidworks exp.  Small component machine injection molded products. B.S. or M.S. in Mechanical Engineering.  Four to six yrs exp.


Research & Development - Electronics / Software

1474
Principal Level Analog Design Engineer   
Southern California - Therapeutic products.
Plant / integrate DFx requirements into production design requirements specifications.  Plan and coordinate system integration / test / debug.  Plan and coordinate verifications and validations.  Design robust, reliable analog circuit boards. Minimum BS Electrical Eng.  MS preferred.  Minimum 10 yrs exp. in an engineering design environment.  Worst case analysis exp.  Stepper motor driver design exp.  Switch mod and linear power supply design exp.  Circuit board test and verification.  Exp. in DFT, DFM and DFR.



Manufacturing / Operations

1467
Mfg Engineer   

Southern California - Catheters, Guidewires.
Will support
development of products for medical device with work including writing or verifying specifications, maintaining product process, designing fixtures, test processes, equipment and raw materials to ensure the concepts and/or prototypes meet their requirements.  Will interact and work closely with R&D Team.  Degree in related field or exp.  R&D exp.  Pro/E or Solidworks proficiency preferred.

1479
Mfg Engineer 

Southern California - Minimally Invasive; Sutures
Mfg Eng. candidate must have complete familiarity with current GMP's, IQ, OQ, PQ activities; process validations and verification; statistical methods. Ability to design jigs and fixtures to improve manufacturing processes.  Should be hands-on.  Appropriate undergraduate degree minimum. At least 5 yrs exp. in a medical device company, preferably hand-held instruments of a moderately complex nature.

 

Quality / Regulatory / Clinical Affairs


1470
Regulatory Affairs Mgr. 
Bay Area - Cardiovascular.
Will manage the company's regulatory affairs department as directed by the Vice President of Regulatory Affairs and Quality Assurance.  Oversee the preparation of new and audit / improve existing Technical Files and/or Design Dossiers.  Prepare new domestic regulatory submissions including, but not limited to, 510(k) submissions, IDE's facility registrations, and other annual reports as necessary.  Perform internal quality audits in support of QSR and ISO 13485:2003 compliance and the Quality Assurance function.  

1475
Regulatory Affairs Project Mgr.  
Southern California - Catheters, Guidewires.
Will assist the Director, RA with management of regulatory submissions and compliance programs for new products on a world-wide basis.  Play a key role in the preparation of regulatory submission (e.g. 510(k)s, Design Dossiers; potentially IDEs and PMAs) for intravascular, catheter-based products.  BS / BA n Science, Engineering or Medical Technology or equivalent exp.  Five to seven yrs. exp. in Regulatory Affairs.  Knowledge of FDA, QS & ISO 13485:2003.  Strong knowledge of Regulatory submission and compliance requirements for the U.S., Canada, European, and other international markets for sterile, intravascular catheters and implants.

1478
Quality Assurance Mgr. 
Southern California - Catheters, Guidewires.
Will manage department of QC inspectors (incoming and finished product).  Will resolve product and quality discrepancies.  Will develop and implement quality procedures and departmental procedures pertaining to the Quality System. Participate in third-party audits including FDA and Notified Body Inspections.  Degree in related field or equivalent.  Minimum 5 yrs related exp.  Audit exp. necessary.
 

Sales & Marketing

Currently there are no Sales or Marketing positions at this time.


Management

1465
Director R&D  
International - Insulin Pumps.
Will lead a team to develop a new generation of insulin pump. BS or MS in an Engineering field. Minimum 5 yrs. work exp. in insulin pump and related medical device industry. Must be fluent in Chinese.  Will work in Shanghai, China.

1466
Quality Engineer Dir. 

Bay Area - Cardiovascular Products.
Work with R&D to establish quality requirements at all phases of product/process development and manufacturing.     Design, schedule, perform tests for existing and new products.   Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem.  BA/BS in Eng., MS in Eng. preferred. Minimum 5 yrs exp. in Quality Eng. in Medical Device industry. Exp. with catheters and electro-mechanical manufacturing environment preferred. ASQ certification a plus.

1480
Director of Regulatory Affairs  

Southern California - Pharmaceutical, Cardiovascular
Will be responsible for the company's regulatory interactions in the U.S. and in Europe.  Act as primary contact with the FDA. Selection and management of external consultants to assist in the development of global regulatory strategy for the company's development programs. 
MS / PhD / Pharm  D.  Minimum of 8-10 yrs exp. in drug development.  Minimum 5 yrs. exp. in regulatory affairs with pharmaceutical company and/ or regulatory agency.  Significant role in the compilation of at least 1 IND and NDA.  Strong strategist in RA.  Some start-up or small company exp.


HERE ARE SOME PREVIOUS POSITIONS FROM KMT THAT ARE NOW CLOSED

Please E-Mail your Résumé or Job Description to "new@kuhnmed-tech.com"

KUHN MED-TECH INC.
Executive Search Consultants
for the Healthcare and Biomedical Industry.
Confidential and personalized. Retained or exclusive contingency.
Fund raising for start-up ventures.


28512 Las Arubas
Laguna Niguel, CA 92677
949-600-8365
FAX 309-416-2920 

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