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Hyperfine | AI-Powered Portable MRI · 2 months ago

Lead Engineer, Manufacturing & Process Engineering

Guilford, Connecticut

Full-time

Onsite

Senior Level, Lead/Staff

$125K/yr - $145K/yr

5+ years exp

Hyperfine, Inc. is a groundbreaking health technology company that has redefined brain imaging with the Swoop® system. They are seeking a Lead Engineer for Manufacturing and Process Engineering to support hardware manufacturing and supply chain operations, ensuring reliable and cost-effective medical device production.

Medical Device

No H1B

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

Qualification

Manufacturing EngineeringProcess ImprovementMedical Device KnowledgeERP SystemsData AnalysisCommunication SkillsCollaborationOrganization SkillsAdaptabilitySelf-Motivated

Required

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)

Excellent written communication and verbal communication skills for interacting with diverse teams, stakeholders, and external partners

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

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

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

Strong organizational skills with attention to detail and the ability to manage and prioritize multiple competing priorities

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

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