Senior Advanced Manufacturing Engineer

Job Description

Job Description

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions, Inc. is seeking a motivated and experienced Senior Advanced Manufacturing Engineer to join our dynamic team. In this role, you will play a key part in bridging R&D and Manufacturing by leading the design and transfer of products and process technologies.

You will be responsible for driving Design for Excellence (DFX) initiatives and leading process development to ensure scalability, efficiency, and quality in manufacturing. Your expertise will directly impact operational success and support BrioHealth’s mission to deliver innovative solutions for patients with advanced heart failure.

Responsibilities

Design Transfer

• Collaborate with R&D, Manufacturing Engineering, and Quality to successfully transfer products into manufacturing.
• Lead the design transfer process, ensuring all activities align with project plans and that processes are production-ready.
• Design and develop manufacturing processes, tooling, and fixtures to enhance safety, quality, productivity, and scalability.
• Lead all process validation activities, including the creation and execution of IQ / OQ / PQ protocols, validation plans, and reports.
• Drive cost-effective solutions by monitoring and influencing product Cost of Goods Sold (COGS) during concept and design phases.
• Facilitate and lead the pFMEA process as a core member of the project team.

Process Support & Improvement

Supplier Management

Cross-Functional Collaboration

Leadership & Other

Qualifications