Mechanical or Biomedical Engineer - Product Design & Development

Overview

Design, prototype, and validate a Class II medical device from concept to FDA submission.

Key Responsibilities

• prototype testing
• system integration
• bench testing
• risk analysis
• bom creation
• mechanical design

Tasks

-Build and test prototypes for airflow, pressure, vibration, and structural performance -Collaborate with electrical, firmware, and manufacturing teams to integrate systems -Participate in bench and environmental testing for verification and validation -Contribute to risk analysis, labeling, and regulatory documentation -Support DFM, BOM creation, and documentation under FDA design control -Design and model mechanical subsystems and assemblies using Autodesk Inventor

Requirements

• mechanical eng
• additive manufacturing
• iso 13485
• fluid dynamics
• prototyping
• adaptable

What You Bring

-Up to five years of experience in product design or medical device development -Curious, adaptable, and motivated to learn in a fast-paced, collaborative environment -B.S. or M.S. in Mechanical or Biomedical Engineering -Experience in machining, additive manufacturing, or test fixture design -Familiarity with ISO 13485, IEC 60601, or FDA 510(k) processes -Strong fundamentals in fluid dynamics, pressure systems, and mechanical design -Hands-on experience with prototyping or lab testing

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Benefits

-Health insurance stipend (QSEHRA) and 401(k) -Paid vacation and holidays -A front row seat in a fast-growing, mission-driven medtech startup -Competitive salary and equity opportunity

About Enexor Bioenergy

-Engineers modular Bio-CHP systems that transform local organic and plastic waste into 24/7 power and heat. -Commercialized first Bio-CHP units in early 2021 after UNWTO recognition. -Flagship Bio-200 units are housed in 20-foot shipping containers, ready for microgrids and rental sites. -Clients cut waste disposal costs and earn energy from their own waste via an Energy-as-a-Service model. -Selected by accelerators including Google Climate Change, Plug and Play Asia, Halliburton Labs, and UNWTO. -Deployed across retail, military, hospitality, and remote communities, including pilots in Asia, the Caribbean, Vermont, and military bases. -Plug-and-play units offer off-grid resilience and scalability, withstanding harsh conditions like hurricanes.

Sector Specialisms