2063 Metz Lane
San Diego, CA 92111
Job Objective To obtain a position in order to maximize my skills as a Product Safety Engineer and also to improve the company as a whole through my own skills and abilities.
Highlights Of Qualifications:
- Remarkable experience designing for compliance to FDA Medical Device regulations and of executing probabilistic analysis
- Operational knowledge of ISO 14971, SEMI S2, S8, F15, NFPA 79, EN60204-1 EN 60950, EMC, LVD and MD CE marking directives
- Good understanding of global industry safety codes, standards and regulations
- Ability to manage under pressure and in a team environment
- Ability to outline technical files
- Superior communication skills
- Excellent team building, leadership and interpersonal skills
Product Safety Engineer, August 2005 – Present
GE, San Diego, CA
- Managed investigation of field safety incidents.
- Supported root cause analysis.
- Conducted incident risk modeling on systems.
- Supervised the design team and smoothened proactive product safety reviews.
- Conducted hazard assessments.
- Assured compliance with all aspects of product safety.
Product Safety Engineer, May 2000 – July 2005
Yoh, San Diego, CA
- Aided safety, regulatory and code compliance activities.
- Delegated to analyze corrective actions and handled customer inquiries.
- Analyzed customer safety specifications and product literature.
Bachelor’s Degree in Engineering Management, South Georgia College, Douglas, GA
Master’s Degree in Engineering Management, West Virginia University, Morgantown, WV