Mechanical Engineer II

BRIOHEALTH SOLUTIONS INC•Burlington, MA

20d

About The Position

BrioHealth Solutions Inc. is seeking a Mechanical Engineer II to join our Research & Development team. This engineer will contribute to both current and next-generation platform development, supporting work from early concept through verification, validation, and transfer to manufacturing. The role requires strong mechanical design fundamentals, hands-on engineering execution, and the ability to operate in a fast-paced Class III medical device environment. The ideal candidate will design and analyze mechanical components and assemblies, run and document testing, troubleshoot issues with cross-functional partners, and drive incremental improvements to system performance, reliability, and manufacturability.

Requirements

Bachelor’s degree in Mechanical Engineering required; Master’s degree preferred.
3+ years of engineering experience in R&D or product development (or 2+ years with a Master’s).
Experience working within FDA Quality System Regulations (21 CFR 820) or another highly regulated industry strongly preferred.
Strong interpersonal and decision-making skills with the ability to influence across functions.
Proven ability to communicate complex technical concepts to both technical and non-technical stakeholders.
Demonstrates initiative, creative problem-solving, and a positive, solutions-oriented mindset.
Proficient in computer-aided design and simulation tools; SolidWorks experience preferred.

Nice To Haves

Exposure to medical electronics, cardiovascular physiology/pathophysiology, or implantable medical devices is a plus.

Responsibilities

Lead engineering initiatives from early concept through full product release, ensuring technical rigor and on-time delivery.
Own external development partnerships, including suppliers, consultants, and specialized engineering resources.
Apply sound engineering judgment to drive decisions, perform structured technical analyses, and contribute actively to cross-functional project teams.
Design and analyze mechanical components using CAD and FEA tools to meet performance, safety, and reliability requirements.
Continuously evaluate emerging technologies, materials, and manufacturing methods to strengthen product performance and scalability.
Diagnose root causes of complex technical issues and implement durable, practical solutions.
Plan and execute verification and validation testing to confirm compliance with quality, reliability, and regulatory expectations.
Produce complete and accurate documentation across the product development lifecycle (design history, reports, test protocols, etc.).
Translate academic fundamentals and practical engineering experience into innovative, manufacturable design solutions.
Communicate clearly and proactively across a global, multi-site engineering organization.
Collaborate closely with Manufacturing, Quality, Regulatory, and Clinical teams to support design transfer, risk management, and commercialization activities.