Senior Electrical Engineer

The Opportunity

This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions.

We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our Senior Electrical 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

• Ensure that electrical design and test equipment meet applicable industry and medical device standards.
• Specify, design, verify and validate, sustain very low-power analog front-end design and battery-powered embedded systems per applicable regulatory standards for medical devices.
• Provide expertise in EMC / EMI, radio and safety regulatory standards.
• Proficient in PCB layout using Altium design tools.
• Develop and execute V&V test protocols.
• Work with project teams on risk files and labeling for compliance to regulatory standards.
• Communicate effectively to and participate in cross-functional development teams.
• Write and submit Engineering Change Orders in Agile (a product life cycle management tool.)
• Address parts obsolescence and investigate complaints.
• Act as an independent reviewer on programs not directly involved.
• 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
• Mastery of fundamental Electrical Engineering principles.
• 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.
• Experience in performing complex engineering calculations and relating results to design verification tests including statistical analysis and tolerance analysis
• Working knowledge in writing process, product requirements, and design specifications.
• Understanding of processes used in the design and manufacturing of medical devices, particularly those for high volume, very low-current, battery-powered handheld, wearable, and body-worn devices.
• 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.

Preferred

• Master’s Degree in Electrical Engineering
• Preferred Skills / Technologies : PCB layout using Altium design tool, EMC design and test (NFC, BLE, Cellular), DFM, DFT, ultra-low power analog design, Agile PLM tool, design requirement management tools such as DOORS and SysML
• 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
6 days ago