Skills
- ELECTRICAL ENGINEER
- ELECTRICAL ENGINEERING
- ELECTRONICS ENGINEER
- MEDICAL DEVICE
- MEDICAL MACHINARY
- MEDICAL DEVICE COMPANIES
- MEDICAL DEVICES
- HOSPITAL DEVICES
- CLINICAL DEVICES
Job Description
100% Onsite. No Relocation.
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
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
- 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
- BS in Electrical Engineering