Principal Mechanical Engineer - medical device

I am a recruiter with a cutting-edge medical device start-up company located in the Buffalo, NY area with over five years of development invested in a cutting-edge infusion technology.

The device is a touch-screen-driven system that connects to hospital networks via Wi-Fi and incorporates advanced cybersecurity features. It also supports Bluetooth and NFC connectivity. The device uses proprietary vision-based technology to directly measure flow rate.

The initial product launch is focused on medication delivery from IV bags, with subsequent product releases planned to support syringe-based delivery.

We anticipate that this technology will significantly enhance patient safety and advance the infusion device market.

The Principal Mechanical Engineer provides technical leadership for the mechanical design and development of medical devices, with a particular focus on building robust products and processes that will succeed as production volume, complexity, and customer expectations increase.

This role is expected to take ownership of difficult technical problems, identify risks and opportunities before they become problems, and independently determine what needs to be investigated or improved. The Principal Mechanical Engineer will apply strong mechanical engineering fundamentals, practical design and manufacturing experience, rapid prototyping, analysis, and testing to develop solutions that are innovative, reliable, manufacturable, and serviceable.

This is a hands-on technical leadership role. The Principal Mechanical Engineer will influence product architecture and design decisions, provide technical guidance to other engineers, and work across engineering, manufacturing, quality, purchasing, and other functions to drive successful products from concept through production.

Minimum Qualifications; Knowledge, Skills and Abilities:

1. BS in Mechanical Engineering or equivalent experience.
2. 10+ years of experience as a mechanical engineer, in a medical device company, or some other regulated industry like aerospace or automotive.
3. Excellent communication skills
4. Track record of strong leadership
5. Experience with plastic injection molding

Additional Qualifications; Knowledge, Skills and Abilities:

1. Experience with destructive testing, such as Highly Accelerated Life Testing.
2. Experience with fluid valve design preferred.
3. Experience in the medical industry or another regulated field.
4. Experience with IEC 60601 preferred.

$125,000-150,000 base salary + 10% Bonus

MUST BE a U.S. Citizen or Green Card holder