Lead Engineer, Manufacturing & Process Engineering

Hyperfine•Guilford, CT

23h•$125,000 - $145,000•Onsite

About The Position

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.

Requirements

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 every day ethos.
Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering or related field (or equivalent experience)
5-8 years of experience in a manufacturing operations or manufacturing engineering role, ideally within a regulated industry (medical device).
Proven track record managing contract manufacturers and/or in-house production operations.
Experience developing and maintaining manufacturing documents under quality system requirements (FDA, ISO).
Experience with ERP systems (e.g., NetSuite) and data-driven process improvement methods (Lean, Six Sigma, SPC)
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa.

Responsibilities

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.
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.
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.
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.