Sr. Hardware Compliance Engineer at Abbott Laboratories

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

 
The Opportunity 

Our Sr. Hardware Compliance Engineer located in Alameda or Milpitas, California 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: 

Training and career development, with onboarding programs for new employees and tuition assistance  
Financial security through competitive compensation, incentives and retirement plans  
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 
The stability of a company with a record of strong financial performance and history of being actively involved in local communities 
Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

The base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.