Senior Electrical Engineer – ASIC

The Senior Electrical Engineer will be working independently in a lead role, or as part of a team to design, develop, and troubleshoot critical electrical designs. Will identify, recommend, implement significant and/or complex new electrical design improvements or technologies that meet regulatory requirements. May lead multiple electrical engineering activities. Will develop cross-functional working relationships and provide effective communication to Senior Management.

RESPONSIBILITIES:

• Research, specify, design, verify, and validate low-power analog front-end designs and battery-powered embedded systems per applicable regulatory standards for medical devices.
• PCB layout, Altium design tools preferred. Anticipate and resolve DFM and DFT issues.
• Lead ASIC development activities including defining requirements, specifications, design & development, characterization
• EMC/EMI design and testing for regulatory standards.
• Develop product specifications, design FMEAs, and V&V test protocols.
• Ensure that electrical design and test equipment meet applicable industry and medical device standards
• Communicate effectively to and participate in cross-functional development teams.
• Create and review electrical design specifications and product requirements.
• Write and submit Engineering Change Orders
• 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

EDUCATION AND EXPERIENCE:

• • Bachelor’s Degree in Electrical Engineering
  • Minimum 10 years of relevant experience
  • Mastery of fundamental Electrical Engineering principles.
  • Solid knowledge of regulations and industry standards for medical device development including but not limited to   ISO 13485, ISO 14971, and FDA Guidance for medical device development.
  • Experience in writing ASIC development requirements and specifications and providing detailed technical reviews
  • Experience successfully designing circuits, analytical and numerical modeling, discrete component implementation, and benchtop characterization
  • Experience successfully designing PCBs, developing specifications, and providing technical reviews
  • Experience with developing design verification protocol, execution, and report generation
  • Experience with manufacturing test development, requirements, specifications, and limits generation.
  • Experience in performing complex engineering calculations and relating results to design verification tests including statistical analysis and tolerance analysis
  • Working knowledge in the writing process, product requirements, and design specifications.
  • Understanding of processes used in the design and manufacturing of medical devices, particularly those for very low-current, battery-powered handheld, wearable, and body-worn devices.
  • Excellent written and verbal communication skills.

PREFERRED:

• • Master’s Degree in Electrical Engineering
  • Preferred Skills/Technologies: PCB layout using Altium design tool, Cadence (or equivalent) ASIC development tools, programming/scripting (C, C++, Python, or equivalent), EMC design and test (NFC, BLE, Cellular), DFM, DFT, ultra-low power analog design, requirement management tools such as DOORS and SysML