Principal Engineer

PRINCIPAL ENGINEER

JOB DUTIES:

-Design history file review to collect, review, and update as necessary, risk assessment and Design FMEA documentation on existing market released devices
-Diagnostic and therapeutic medical devices and device programmers
-Provide support for released products, evaluate field performance and recommend corrective action when necessary
-May provide leadership to others
-Prepare, review and approve Qualification Test Plans and Reports for assigned projects
-Provide technical support for technicians performing the testing
-Assure the resolution of all issues raised by the testing
-Prepare, review and approve Reliability Predictions for assigned projects
-Review and approve changes to products in production for reliability impact to aid in the correction of process, design or materials problems
-Evaluate field performance of assigned products by reviewing field data, supporting technicians to evaluate unusual returns and supporting Technical Services and Consumer Affairs in responding to customers
-Support Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met
-Support Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests for approval to the FDA
-Investigates and evaluates product field problems.
-This includes preparing Product Field Impact Reports and Health Hazard Analysis and working with Marketing, Product Development and Regulatory on field action plans
-Maintain expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements
-Take on special projects in which only the results are specified and complete them on schedule.
-This may involve making presentations/recommendations to management
-May supervise technicians and/or engineers.

INDUSTRY EXPERIENCE:

Greater than 5 Years

ORAL COMMUNICATION:

Excellent

Facilitation Skills

RELIABILITY ENGINEERING EXPERIENCE:

Greater than 5 Years

SOFTWARE APPLICATION KNOWLEDGE/ENGINEERING:

Acrobat Reader

MS Exchange

MS Outlook

MS Visio

MS Word

MS Access

MS Excel

MS PowerPoint

MS Project

WRITTEN COMMUNICATION:

Excellent