SrTechnical Lead

Role : Sr.Technical Lead Urgent
Location: Boston MA onsite

Keywords : Circuit design Medical devices Product Development ISO13485 ISOFMEA EMI/EMC USB Microprocessor Microcontroller Embedded Systems Agile Obsolescence Sustaining support Integration Verification Risk Management Medical Devices Medical Standards Change Control

JD:

strong HW board design experience and Medical domain.
Alternate supplier identification for selected components
Design document updates
Extensive experience in microcontroller (latest models) CPLD/FPGA and/or digital logic Serial protocols (USB I2C SPI RS232 etc.)
Must have strong knowledge in various design analysis for digital board & Mixed signal designs such as timing noise margin part stress DFMEA and worstcase analysis.
Previous experience in analog control electronics sensor and solutioning
Must have circuit design experience (Mentor Expedition OrCAD OR equivalent Expedition is preferred)
Experience in electrical requirements board specification and system requirement writing.
Knowledge on Embedded software and good understanding on communication interfaces like USB Ethernet.
Comfortable with working in a lab environment and executing hands on testing.
Must have knowledge in EMI/EMC compliance design and testing.
Experience in working with medical diagnostics device or equivalent systems (Mandatory)
Experience in Field issue resolution obsolescence eradication BOM scrubbing.
Knowledge on Medical device compliance standards IEC60601X (Mandatory) ISO14971 ISO13485
Must be familiar with technical work instruction and drawings and good documentation practices.
Creating Board (PBCA) Test Plan and Test Protocols.
Board (PCBA) Testing and debugging support.
Experience in closely working with system and subsystem teams and fully understand electrical mechanical and software interfaces between subsystems and the corresponding flow of data/information.
Experience in tracking issues associated with subsystem releases identifying the responsible team(s) and subsystem(s) communicating with the concerned personnel and driving issues through to resolution.
Support new product introduction (NPI) transition from design to manufacturing.
Mandatory Skills:

Bachelors Degree in Electrical Engineering (or equivalent) preferred
10 years of Electronic Design Experience & Embedded product development
Previous experience with complex electrical/electromechanical product development
Experience in medical product development and testing
Excellent communication skills & interaction with multiple stake holders/functions