Principal Mechanical Engineer - medical device

DeBellis Catherine & Morreale - Corporate Staffing; Town of Tonawanda (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

DeBellis Catherine & Morreale - Corporate Staffing seeks a Mechanical Engineer for a cutting-edge medical device start-up focused on infusion technology. You will research, develop, and test mechanical features, including sealed housings, valves, and mounting supports, ensuring designs meet industry standards.

You will model in CAD, produce GD&T drawings, build prototypes, and support 510(k) submissions and design transfer.

Qualifications

• BS in Mechanical Engineering or equivalent experience.
• 10+ years of experience in a medical device company.
• Experience with plastic injection molding.
• Must be a U.S. Citizen or Green Card holder.

Responsibilities

• Research, ideate, develop, test, and improve mechanical features for medical devices.
• Model designs in CAD and generate drawings with GD&T; build prototypes.
• Write Engineering Development Plans and Design Requirements with cross-functional stakeholders.
• Contribute to 510(k) submissions and Design Transfer.
• Perform design analyses including Thermal, Tolerance Stack-Up, FMEA, and Reliability.

Education

BS in Mechanical Engineering

Tools

CAD

GD&T

Job description

I am a recruiter with a cutting-edge medical device start-up company 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 device is currently in formal development, with a 510(k) submission planned for September 2026.

Job Summary:

Mechanical Engineer to research, ideate, develop, test, and improve the mechanical features for medical devices. Features include, but are not limited to, sealed housings, fluid valves, latch mechanisms, mounting supports for electronic hardware, etc.

• Think outside the box.
• Ideate innovative concepts for solving engineering challenges.
• Rapidly prove/disprove those concepts through feasibility testing, leveraging tools such as 3D printers.
• Write Engineering Development Plans for projects.
• Develop concise and intelligent Design Requirements, through collaboration with key cross functional stakeholders.
• Read, understand, and design in compliance with applicable industry standards.
• Model designs in CAD and generate associated drawings with Geometric Dimensioning and Tolerancing as appropriate for prototyping and production. Build prototypes for evaluation and testing.
• Conduct Design Reviews and Technical Reviews.
• Perform relevant design analysis, including analysis of:
• Thermal
• Tolerance Stack-up
• Failure Modes and Effects
• Reliability

• 10.Write test plans and protocols for Verification of Design Requirements.
• 11.Perform statistical analysis on data.
• 12.Write reports to summarize results and conclusions.
• 13.Manage Design Configurations for clear traceability to what was tested.
• 14.Track and troubleshoot issues that are identified.
• 15.Continuously improve designs.
• 16.Continuously improve processes.
• 17.Contribute and support preparation of 510k submissions.
• 18.Support Design Transfer.
• 19.Drive success relentlessly.

Additional Responsibilities:

• Work closely with system architects and other design engineers to ensure that the design meets the end users’ needs.
• Endlessly learn and improve.
• Other duties as assigned.

Minimum Qualifications; Knowledge, Skills and Abilities:

• BS in Mechanical Engineering or equivalent experience.
• 10+ years of experience, in some type of medical device company

4.Experience with plastic injection molding.

Additional Qualifications; Knowledge, Skills and Abilities:

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

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