Sr. Hardware Compliance Engineer

$109,300 - $218,500/Yr

Abbott Laboratories - Milpitas, CA

Full-time - Mid Level

Milpitas, CA

10,001+ employees

Miscellaneous Manufacturing

About the position

The Sr. Hardware Compliance Engineer at Abbott plays a crucial role in ensuring compliance with EMC, radio, and safety standards for medical devices. This position involves leading compliance efforts, developing verification plans, and collaborating with cross-functional teams to maintain regulatory standards. The engineer will also communicate compliance status to management and document necessary changes in product life cycle management tools.

Responsibilities

• 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.

Requirements

• Bachelor's Degree in Electrical Engineering
• Minimum of 7 years of relevant experience, including roles such as 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 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.

Nice-to-haves

• Design for EMC and test (NFC, Bluetooth, WiFi, Cellular)
• Agile PLM tool experience
• Project management skills
• Experience setting up and maintaining Anechoic chamber and ESD spaces.

Benefits

• Career development with an international company
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement and FreeU education benefit
• Recognition as a great place to work
• Training and career development programs
• Financial security through competitive compensation and incentives
• Health care and well-being programs including medical, dental, vision
• Paid time off
• 401(k) retirement savings with a generous company match