POSITION REQUIREMENTS:
A Bachelor's degree (Masters preferred) in Engineering or related field and 5+ years of related experience is required.
Experience must include applying medical device standards throughout the product lifecycle to support worldwide market clearances such as 510(k), CE Mark.
SKILLS
"Detailed knowledge of the applicable industry standards and regulations.
"A working knowledge of Nationally Recognized Testing Laboratories (NRTL's).
"Excellent verbal and written communication skills with solid technical writing skills.
"Excellent problem solving/analytical abilities.
"Ability to manage multiple tasks in a time sensitive environment.
"Ability to work productively and proactively with technical, multi-disciplinary product teams.
"Solid product management and organizational skills.
"Proven ability to translate technical documentation such as regulations into effective, compliant documentation necessary for regulatory submissions.
"Training experience considered a plus.
"Experience with RoHS, REACH, Conflict Minerals, and WEEE a plus.
"Certifications considered a plus.