Sr. Electrical Sustaining Engineer - Marlborough, MA

Sr. Electrical Sustaining Engineer - Marlborough, MA

Marlborough, MA, United States

Sr. Electrical Engineer, Product Engineering, delivers value by:

• Maintaining hardware continuity of our existing portfolio.
• Driving design improvements that enhance quality, performance, compliance, reliability and cost-effectiveness.
• Enhancing the user experience through state‑of‑the‑art hardware design and selection, robust testing and thorough analysis.
• Serving as a key stakeholder and collaborator with Regulatory, Quality, Manufacturing and external suppliers.

• Lead troubleshooting of electrical and electro‑mechanical systems for field‑returned units, determining root cause and implementing design changes aligned with quality and risk imperatives.
• Lead hardware design efforts for product line extensions, value‑improving projects (VIPs) and new features for existing products.
• Develop electrical test fixtures and/or prototype boards to support root cause investigations and design improvements.
• Support Manufacturing with process and fixture improvements related to critical hardware.
• Collaborate with strategic sourcing partners to implement technical cost‑out design changes.
• Interpret current verification methods for electrical components, PCBs and subsystems and enhance them to ensure state‑of‑the‑art practices.
• Lead technical communication with component and PCB suppliers to resolve issues and improve designs.
• Build and maintain strong collaborative relationships with key internal and external stakeholders.
• Stay current with emerging technologies and processes to support ongoing innovation.
• Develop verification strategies for design changes that align with the Hologic QMS and product Risk Management files.
• Lead and/or support multiple projects across multiple products simultaneously, coordinating with Quality and NPD SMEs on root cause and design activities.
• Maintain existing product lifecycle by safeguarding against electrical component end‑of‑life (EOL), from single components to large‑scale EOL programs across multiple PCBs/products.

• Bachelor’s or Master’s in Electrical Engineering.
• Strong understanding of analog and digital circuit design, including microcontrollers and power delivery circuitry.
• PCB‑level design and schematic capture (preferably using Altium).
• Electrical and electro‑mechanical system behaviour and failure modes.
• IEC 60601 safety and EMC requirements for medical electrical equipment.
• Design for Manufacturing (DFM) principles as they apply to electrical engineering.
• Familiarity with:
  • FPGAs and CPLDs.
  • Embedded systems and the interaction between hardware and software.
  • Medical device product development, lifecycle management and sustaining engineering.
  • Quality Management Systems (QMS) and Risk Management (e.g., risk files, verification strategies).

• Ability to troubleshoot and determine root cause for failures in PCBs and electro‑mechanical systems.
• Schematic‑level hardware design, including component selection and design updates for sustaining and cost‑out initiatives.
• Proficiency with electrical test and development equipment:
  Oscilloscopes, LCR meters, Logic analyzers, Power supplies.
• Development of test fixtures and prototype boards for verification, validation, and root‑cause analysis.
• Application of design‑for‑manufacturing and design‑for‑reliability principles in electrical designs.
• Interpretation, execution and improvement of verification methods for components, PCBs and subsystems.
• Proficient in generating technical documentation (test protocols, test reports, design descriptions, and engineering justifications).
• Ability to effectively communicate complex technical topics to both technical and non‑technical audiences.
• Strong cross‑functional collaboration with Quality, Regulatory, Manufacturing, Sourcing, and R&D.
• Ability to lead technical discussions with external suppliers (components, PCBs and other hardware suppliers).

• Structured problem‑solving and root cause analysis in a regulated environment.
• Ability to manage and prioritise multiple projects across multiple products concurrently.
• Ability to develop and execute verification strategies…