Principal Mechanical Engineer (Adraxe)

Adraxe - Company Overview

Adraxe Corporation is an innovative medical device startup focused on the design, development, and launch of breakthrough, minimally invasive neuromodulation solutions to address unmet patient needs. The results from the first 14 patients are encouraging. We are at the important stage of hiring key personnel, to accelerate our progress and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy.

Job Title: Principal Mechanical Engineer

Company: Adraxe

Job Type: Full-Time

Location: Minneapolis, MN (Hybrid)

POSITION OVERVIEW

This role will lead the mechanical design of the Adraxe Implatable Neurostimulator. The role will be responsible for the full lifecycle of mechanical design; defining inputs, generating designs, engaging in component selection, defining manufacturing processes, characterizing performance, optimizing design, verifying performance, and supporting clinical utilization.

The implantable Neurostimulator is a critical component in the Adraxe closed-loop therapy for epilepsy and this position will significantly enable the success of the Implantable Neurostimulator effort and Adraxe as a company.

This position will report directly to the VP of Engineering and will have significant input into Adraxe strategy, planning, and operations.

RESPONSIBILITIES

• The primary duties and responsibilities for this position are:
• Defining mechanical requirements of the implanted neurostimulator.
• Leading the implanted neurostimulator mechanical design.
• Leading component selection to support the mechanical design.
• Guiding manufacturing process selection.
• Planning and completing design characterization.
• Acting as the primary technical contact for the contract manufacturer.
• Planning and completing mechanical verification testing including test method definition.
• Supporting clinical utilization of the implanted system.

QUALIFICATIONS

Minimum Qualifications are:

• Bachelor's Degree in Mechanical Engineering or similar.
• Minimum of 10 years working at a Mechanical Engineer.
• Experience in development of active implanted medical devices.
• Proficiency in CAD and drawing creation including and understanding of GD&T.
• Manufacturing Process development experience.
• Strong written and verbal communication skills.
• Experience selecting and managing component vendors.
• Willingness to operate across the lifecycle of a design.
• Willingness to work on a small team in a fast-paced environment.

Preferred Qualifications are:

• Master's Degree in Mechanical Engineering or similar.
• Operation within a quality system supporting Class III systems.
• Understanding of active implanted medical device implant techniques and past experience supporting systems clinically.
• Understanding of active implantable device standards.
• A history of successful implanted device designs.
• Deep knowledge of manufacturing processes utilized in implanted systems.
• An understanding of statistical test methods.
• A track record of Intellectual Property generation.
• 10+ years working as a mechanical engineer.

WORKING CONDITIONS

• This position will be located in Minneapolis, MN.
• This position will be a hybrid position with an expectation of roughly 75% in office and 25% remote work.
• This position will require approximately 15% Travel.