Description
This is an exciting opportunity for a candidates that fits the below requirements. This position is located in the company's global headquarters in Carlsbad CA.Essential Functions:
1. Develop and implement a test plan that will insure integrity of the structural frame of the implant and meet regulatory requirements for CE, IDE, and PMA approval. Includes:
* Consulting with R&D and regulatory management
* Identifying and interpreting U.S. and international standards, and publications
* Engineering analysis
2. Specific testing includes (but not limited to):
* Managing FEA projects
* Device fatigue testing
* Material fatigue testing
* Material creep testing
* Failure mode identification
3. Manages outside test facilities and consultants
4. Write and implement test methods and design verification protocols & reports
5. Working with regulatory to drafts sections of in vitro regulatory submission
6. Oversee and/or conduct internal testing related implant durability
7. Test method validation
8. Design or oversee the development of test equipment
9. Ensure strict compliance quality system requirements
10. Mentor Jr. engineers, interns, and technicians
11. Independently manage high level projects assigned by R&D management
12. Oversees engineering functions to support product approvals/clearances with FDA and CE Marking
Minimum Requirements:
* Bachelors Degree preferably in Engineering, Biomedical or related scientific field
* 10 years in medical device environment in roles of increasing responsibility
* Proficient in EU and FDA medical device regulations
* Previous experience managing/overseeing R&D projects.
* Experience managing fatigue and FEA projects
* Proficient in Microsoft Office applications, statistical software packages, Solid Works
* A positive, self confident individual that excels in a team oriented environment and possesses strong leadership and decision-making skills
KEYWORDS:Electrical engineer, test engineer, hardware test engineer, hardware engineer, design engineer, medical device, Carlsbad, san diego, Irvine
To find out more about Real please visit www.realstaffing.com