ENGINEERING MANAGER, MEDICAL DEVICES - Minneapolis, MN

The Engineering Manager, Medical Devices will be primarily responsible for the oversight and management of a team of engineers consisting of Systems Engineers, Embedded Software Engineers, Design Engineers and Engineering Technicians.

 

RESPONSIBILITIES:

  • Oversee software system architecture development and document software requirements and development plan

  • Manage the design analysis and review process, leading a hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements

  • Report on and resolve software related issues and see that the resolution of issues is completed with a well-documented and methodical approach

  • Manage your team's software testing and verification plans and protocols, and ensure that prototype testing and verification testing is being conducted

  • Oversee hardware engineering team responsible for debugging and integrating software with hardware

  • Collaborate with other team leaders and managers to create and manage development plans and project plans related to software development

  • Ensure that relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files is created and maintained

 

REQUIREMENTS:

  • BS in a relevant engineering or science discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.

  • Experience with managing projects and personnel involved with microcontrollers (ARM, Texas Instruments), communication controllers (Zarlink, Bluetooth), IC interfaces (SPI, I2C), DSP

  • Management experience overseeing teams responsible for developing firmware solutions

  • A background in Hardware and Software Engineering to capably oversee the work of engineers on the team.

  • Knowledge and understanding of IEC 60601 and IEC 62304 and other relevant medical device regulatory standards

  • Minimum 5 years of experience in project / program management of medical device development programs

  • Demonstrated ability to lead medical device development projects from early stage design through verification/validation, and transfer to production

  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral. Management experience is essential to this position, as is proven skills in the presentation of project plans, progress reports and other materials as needed by senior management.

 

We knows this client very well - the company has an excellent reputation for putting employees first, and for delivering a first-class work environment along with excellent benefits and competitive compensation.

 

This is a growth role, slated to be filled immediately.

 

EngineeringLesley BushMinnesota