Sr. Hardware Compliance Engineer

$109,300 - $218,500/Yr

Abbott Laboratories - Alameda, CA

posted 4 months ago

Full-time - Mid Level
Alameda, CA
10,001+ employees
Miscellaneous Manufacturing

About the position

As a Senior Hardware Compliance Engineer at Abbott, you will play a pivotal role in ensuring that our products meet the necessary compliance standards for electromagnetic compatibility (EMC), radio, and safety. This position requires you to work independently or as part of a team, leading compliance efforts for new product introductions (NPI) and sustaining activities. You will be responsible for supporting all aspects of compliance, including requirements gathering, risk assessments, design verification, testing, labeling, and remediation. Your expertise will be crucial in driving compliance efforts in accordance with relevant global market certifications, ensuring that our products not only meet but exceed industry standards. In this role, you will develop and execute design verification plans and protocols to demonstrate and maintain compliance with applicable standards. This will involve close collaboration with third-party testing labs such as UL, NRTL, and TUV. You will also coordinate compliance activities with cross-functional teams, including system engineers, electrical engineers, program managers, and operations teams, to ensure that all compliance requirements are met throughout the product lifecycle. Your responsibilities will include reading and interpreting technical standards and documentation, providing gap assessments to the latest standards, and effectively communicating compliance status to senior management and cross-functional development teams. You will document compliance status and write and submit Engineering Change Orders using Agile, a product lifecycle management tool. Additionally, you will be expected to comply with all applicable corporate and divisional policies and perform other duties as assigned by the management team.

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, which may include roles such as Electrical Engineer, Systems Engineer, Technical Manager, or 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.

Nice-to-haves

  • Design for EMC and test (NFC, Bluetooth, WiFi, Cellular)
  • Experience with Agile PLM tool
  • 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 Freedom 2 Save student debt program
  • Recognition as a great place to work in multiple countries
  • Diversity and inclusion initiatives
  • Training and career development programs
  • Financial security through competitive compensation and incentives
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • Stability of a company with strong financial performance and community involvement
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