The Planet Group
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Senior Electrical Engineer - Product Development
Andover, MA 01810 US
Posted: 08/21/2023
2023-08-21
2023-10-30
Employment Type:
Direct Hire/Perm
Job Category: Engineering
Job Number: 578296
Country: United States
Is job remote?: No
Job Description
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
· Contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables
· Contribute mainly to new product development but also support existing product line
· Responsible for designing and rapid prototyping concepts and iterating through the design process
· Ensure compliance with Design Control regulations, including, but not limited to, specification development, risk analysis, design reviews and verification and validation protocols and reports
· Work closely with manufacturing engineering to ensure new electrical designs are capable of being assembled and tested using advanced manufacturing automation
· Responsible for writing electrical subsystem verification test protocols and reports
· Collaborate and communicate with cross-functional teams and leadership
· Design and develop PCBA functional test fixtures - LabView experience a plus
· Prepare and execute EMC test plans
· Provide direct support to contract manufacturers for supply of PCB assemblies and PCB-level components
· Generate and through formal change order processes, maintain schematic, PCB and PCBA documents
· Create written specifications and functional description documents
· Prepare for and lead electrical design reviews, and contribute to system-level design reviews
· Work collaboratively with external design services
· Address field issues by determining root cause and implementing corrective actions as necessary
· Perform other tasks and duties as assigned
REQUIREMENTS:
· 8 to 10 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices
· Circuit design experience to Include microprocessor, analog, digital, motion control, power supplies and battery power management
· OrCAD Capture & Allegro PCB Designer experience strongly preferred
· Successful track record of working in high-growth and dynamic organizations
· Demonstrated record of curiosity, innovation and creative problem solving with an entrepreneurial spirit
· Must be reliable, a self-starter, able to work Independently, as well as work collaboratively
· Strong written and verbal communication skills
· Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
· Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components
EDUCATION:
· BS in Electrical Engineering
· Advanced degree strongly preferred
· Contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables
· Contribute mainly to new product development but also support existing product line
· Responsible for designing and rapid prototyping concepts and iterating through the design process
· Ensure compliance with Design Control regulations, including, but not limited to, specification development, risk analysis, design reviews and verification and validation protocols and reports
· Work closely with manufacturing engineering to ensure new electrical designs are capable of being assembled and tested using advanced manufacturing automation
· Responsible for writing electrical subsystem verification test protocols and reports
· Collaborate and communicate with cross-functional teams and leadership
· Design and develop PCBA functional test fixtures - LabView experience a plus
· Prepare and execute EMC test plans
· Provide direct support to contract manufacturers for supply of PCB assemblies and PCB-level components
· Generate and through formal change order processes, maintain schematic, PCB and PCBA documents
· Create written specifications and functional description documents
· Prepare for and lead electrical design reviews, and contribute to system-level design reviews
· Work collaboratively with external design services
· Address field issues by determining root cause and implementing corrective actions as necessary
· Perform other tasks and duties as assigned
REQUIREMENTS:
· 8 to 10 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices
· Circuit design experience to Include microprocessor, analog, digital, motion control, power supplies and battery power management
· OrCAD Capture & Allegro PCB Designer experience strongly preferred
· Successful track record of working in high-growth and dynamic organizations
· Demonstrated record of curiosity, innovation and creative problem solving with an entrepreneurial spirit
· Must be reliable, a self-starter, able to work Independently, as well as work collaboratively
· Strong written and verbal communication skills
· Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
· Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components
EDUCATION:
· BS in Electrical Engineering
· Advanced degree strongly preferred