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Hardware Compliance Engineer
3 months ago
The Opportunity
Our Hardware Compliance Engineer works independently in a lead role, or as part of a team to ensure compliance to EMC, radio, and safety standards. Supports all aspects of compliance including requirements, risk assessments, design, test, labeling and remediation. May lead multiple electrical engineering activities. Develop cross-functional working relationships and provide effective communication to Senior Management.
What You'll Work On
Drive compliance efforts in accordance with relevant standards for global market certifications.
Provide expertise in EMC/EMI, radio and safety regulatory standards for both new product introductions (NPI) and sustaining activities.
Develop and execute design verification plans and protocols to demonstrate and maintain compliance with standards, working with 3rd party testing labs as necessary (UL/NRTL/TUV).
Work closely and coordinate compliance activities with the cross-functional teams, such as system engineers, electrical engineers, program managers and the operations team.
Work with project teams on risk files and labeling for compliance to regulatory standards.
Read and Interpret standards and technical documentation.
Provide gap assessments to latest standards.
Communicate effectively to management both verbally and written. Document and communicate compliance status to cross-functional development teams.
Write and submit Engineering Change Orders in Agile (a product life cycle management tool.)
Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team
Required Qualifications
Bachelor's Degree in Electrical Engineering
Minimum of 7 years of experience of relevant experience. Relevant experience may include Electrical Engineer, Systems Engineer, Technical Manager, Test Engineer.
Experience with RF, EMC and Safety Regulatory compliance.
Solid knowledge of regulations and industry standards for medical device development and in vitro diagnostic device (IVD) including but not limited to ISO 13485, ISO 14971, and FDA Guidance for medical device development design controls.
Working knowledge in writing process, product requirements, and design specifications.
Excellent written and verbal communication skills.
Experience with IEC 60601-1, IEC 60601-1-2, IEC 61326-1, IEC 61326-2-6, EU Radio Equipment Directive (RED), EN 300 330, EN 300 328, FCC Title 47 Part 15, DO-160.
Direct experience obtaining international certification for hardware products.
Knowledgeable in the latest EMC/Safety/Radio regulatory test requirements for both U.S and worldwide.
Preferred
Preferred Skills/Technologies:, design for EMC and test (NFC, Bluetooth, WiFi, Cellular), , Agile PLM tool,
Project management skills
Experience setting up and maintain Anechoic chamber and ESD spaces
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer: