Lead Engineer, Manufacturing & Process Engineering

About Us

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop system-the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Learn More

About

The Role

Job Title:

Lead Engineer, Manufacturing & Process Engineering

Location:

Guilford, CT, USA

Hyperfine is seeking a Lead Engineer for Manufacturing and Process Engineering to support the execution and continuous improvement of our hardware manufacturing and supply chain operations. This role blends hands-on operational leadership with technical manufacturing expertise, ensuring that our production partners and internal processes deliver reliable, compliant, and cost-effective medical devices.

You will oversee day-to-day manufacturing operations with our contract manufacturer (CM) and serving as lead for manufacturing engineering for Hyperfine's warehouse, driving process optimization initiatives, and collaborating cross-functionally with Quality, R&D, and Supply Chain to scale efficient, high-quality production.

Key Responsibilities:

Manufacturing & Operations Oversight

* Manage day-to-day production activities in coordination with contract manufacturers (CMs) to meet quality, delivery, and cost targets.

* Oversee Hyperfine's warehouse operations, ensuring efficient material flow, inventory accuracy, and compliance with storage and handling requirements.

* Partner with Logistics, Quality, and Finance to ensure smooth end-to-end operations from production through shipment.

* Track and report on key manufacturing KPIs such as yield, throughput, and cost performance.

Process & Quality Engineering

* Lead "design for manufacturability" efforts with R&D to ensure products are optimized for scalable production.

* Develop and maintain process documentation including SOPs, work instructions, and process control plans.

* Implement continuous improvement initiatives to reduce cost, improve yield, and strengthen process reliability.

* Support troubleshooting and root cause analysis for manufacturing issues, coordinating with both internal teams and external partners.

* Review and approve Engineering Change Orders (ECOs) for impact to materials, processes, and obsolescence.

Supplier & Partner Management

* Serve as the primary operations liaison with contract manufacturers and key suppliers.

* Evaluate supplier performance and partner on corrective actions to achieve cost, quality, and delivery goals.

* Support supplier selection, equipment evaluation, and process capability reviews.

Cross-Functional Collaboration

* Work closely with Quality, R&D, and Service teams to ensure manufacturing alignment with product design and regulatory standards (FDA, ISO 13485).

* Collaborate with Finance and Supply Chain to support cost forecasting, inventory planning, and operational efficiency initiatives.

Knowledge, Skill & Abilities:

* Communication Skills - Excellent written communication and verbal communication skills for interacting with diverse teams, stakeholders, and external partners.

* Technical Proficiency - Knowledge of all aspects of medical device design, including voice of customer and design requirements, verification and validation, process validation, and design transfer to manufacturing.

* Analytical Skills - Ability to analyze data, identify trends, and make data-driven decisions

* Collaboration - Effectively collaborate and influence stakeholders from a variety of different disciplines to build positive, cross-functional relationship that foster teamwork

* Organization Skills - Strong organizational skills with attention to detail and the ability to manage and prioritize multiple competing priorities.

* Adaptable - Able to thrive in a dynamic, fast-paced virtual environment.

* Self-Motivated - Consistently pushes self and others to achieve challenging goals while maintaining integrity, authenticity, and community and being willing to put into practice the 1% improvement…