Electrical Engineer at ICONMA, LLC

• Electrical Engineer to assist in development and sustaining engineering projects within the Cardiac Arrhythmia and Heart Failure, Electrophysiology division at Client.
• We are focusing on selecting candidate with Electrical Engineering degree and experience related to qualifying alternate electronic and mechanical components for medical products.
• This candidate will be working in a lead role. Works independently (or in a lead role) on qualifying alternate electronic and mechanical components for medical products.
• Exercises independent judgment in reviewing technical specification sheets for alternate parts recommended by Corporate or TPMs, creating change impact documentation with technical assessment to provide reason and justification to support change, working closely with R&D to ensure technical assessment are comprehensive and accurate, and leading reviews of the documentation with cross-functional team consists of Regulatory, Quality Assurance, R&D, Operations, and Global Sourcing, Develops networks involving cross functional/cross departmental groups as well as communication to senior management.

Requirements:

• Bachelor’s degree in electrical engineering ~ Manager not interested in other degrees
• 5+ minimum years of real work experience. Internships, Co-ops, school projects will not be considered.
• Experience and knowledge of cGMP, FDA and ISO13485.
• Medical Device regulatory experience required. No other regulatory experience will be considered.
• Extensive understanding of processes used in the design and manufacturing of medical devices, particularly handheld devices.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard trace, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Shane Brandon

P: (248) 275-1386