The following positions have now been closed
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.
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.
1476
Director of QA
Southern California - Endosurgical products.
Will manage and oversee all aspects of Quality Assurance (to include Quality
Systems, Quality Engineering and Quality Control). Challenge the status
quo and implements continuous quality improvements to meet the growing needs of
the business. Work in close partnership with peers in Operations and
Engineering throughout the product development and commercialization phases to
ensure delivery of products that meet customer expectations and needs.
Bachelor’s Degree (B.S. preferred) or
equivalent plus six or more years related experience, or equivalent combination
of education and exp.
Exp.
with managing FDA and Notified Body inspections and audits.
Quality management experience in
medical device industry; exp. in a small (< 100 employees) company a plus.
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.
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.
1484
Sr.
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. BS or MS in related field.
Knowledge of medical and technical development. Computer skills
including Word, Excel and A-Cad or Solidworks.
1485
Associate
Mfg Engineer
Southern California - Catheters, Guidewires.
Will develop products, research new ideas and establish process development.
Focus is on both theoretical and practical solution development through the
application of the scientific process. BS degree. Two to four yrs
exp. in medical industry. AutoCAD and Solidworks exp.
28512 Las Arubas
Laguna Niguel, CA 92677
949-600-8365• FAX
309-416-2920
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