|at ( view profile)|
|Date Posted||January 13, 2020|
|Address||3591 Anderson Street, Suite 218|
Medical Engineering Innovations, Inc. (MEI), Madison, WI 53704
Join us in the fight against cancer! MEI is a start-up company developing radio frequency (RF) based electro-surgical tools to treat cancer. We’re looking for a Senior Systems Engineer for Medical Devices to join our team. This experienced, results-driven person will be instrumental in obtaining FDA clearance for the SwiftBlade™ System.
Responsibilities and Duties
- Perform Systems Engineering tasks of various complexities with independence, competence, and attention to detail.
- Lead resolution of Systems Engineering issues including architecture, hardware, and software design trade-offs.
- Create and modify complex electronic assemblies.
- Advance the development of an RF generator system in compliance with IEC 60601 electrical safety standards.
- Design, configure, and test device software.
- Design electrical schematics and PCB layouts and create Gerber files for sourcing of boards.
- Interpret customer requirements, break them down into sub-system and component requirements, and document for regulatory submission.
- Create sub-system and component designs and specifications in support of Medical Device design requirements.
- Prepare reports to communicate design decisions and/or test results for technical and regulatory audiences.
- Maintain bills of materials for project.
- Oversee prototyping, troubleshooting, and debugging of product.
- Oversee product verification and validation testing and trace documentation; make modifications as required.
- Author and manage design-related quality documents to demonstrate compliance with applicable ISO standards and FDA regulations.
- Assist with the writing of regulatory submissions.
- Comply with the company quality system.
- Assure product quality by utilizing design-for-assembly, design-for-test, and design-for-manufacturability principles.
- Utilize and validate design-related software tools.
- Support design control compliance through design reviews, risk analysis, reliability analysis, ECO processes, requirements traceability, etc.
- Directly interface with manufacturing contractors to ensure successful completion of project from development through manufacture.
- Research and develop future products and improvements to existing design.
- Perform other duties as assigned or required.
Required Qualifications and Skills
- Bachelor of Science degree in Systems Engineering, Electrical Engineering, or Biomedical Engineering, with 5 years’ experience; or 10+ years’ experience in Systems Engineering for Medical Device design
- Experience in developing device(s) specific to establishing product requirements, product specification, risk management, verification and validation, etc.
- Experience in designing in compliance with IEC 60601 electrical safety standards
- Experience with high-level design including system-level architecture, design trade-offs, and constraints
- Experience with microcontrollers, FPGA, and ARM
- Experience with RTOS
- Experience with analog and digital circuit design including schematics and PCB layout
- Experience using CAD systems for schematic entry and PCB layout
- Experience performing electrical tests using DMMs, oscilloscopes, logic analyzers, and other standard tools
- Organizational skills/hands-on experience working with multi-functional teams
- Familiarity with Microsoft Office applications
- Skilled in verbal and written communications
- Interpersonal, time management, and organizational skills
Additional Desired Experience
Extra consideration will be given to candidates who have experience with the following:
- Medical device development
- RF device development
- Embedded firmware to deliver required functions
- LTspice simulation software
- Atlassian software tools
Benefits include Medical, Dental, 401K, Disability and Life insurance, Vacation, Paid Time Off, and more.
Our location offers free parking and is served by Madison Metro Transit.
Please submit your resume for the position of: Senior Systems Engineer.