Senior Electrical Engineer

What you'll do

• Develop and release new cardiac rhythm management products and design changes with cross-functional teams.
• Lead and integrate Design for Reliability (DfR) activities to drive product safety and quality outcomes.
• Evaluate designs for potential failure modes and identify appropriate risk controls to mitigate hazards.
• Define reliability requirements and lead reliability demonstration strategies for product development projects.
• Develop test plans, determine sample sizes, and analyze data to demonstrate product performance.
• Articulate risk management activities and conclusions in regulatory submissions and audit documentation.
• Perform engineering reviews of quality records to assess safety and reliability impacts.
• Advocate for safety, reliability, and quality standards during design reviews and project meetings.

What we're looking for

• Bachelor’s degree in Science, Technology, Engineering, Math, or a related technical discipline AND a minimum of 4 years of experience.
• Master's degree with a minimum of 2 years of technical experience.
• Unrestricted U.S. work authorization.
• Experience applying Six Sigma development methods such as DOE, P-Diagram, and Capability Analysis (preferred).
• Strong circuit analysis and hands-on electrical testing experience (preferred).
• Experience using design verification, troubleshooting skills, and working knowledge of quality and statistical methods (preferred).
• Experience writing engineering documents such as test plans and reports (preferred).
• Medical Device Industry experience or other regulated industry experience (preferred).
• Familiarity with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971, and ISO 5841-2 (preferred).
• ASQ CRE Certified (preferred).