Lead Engineer, Manufacturing & Process Engineering

About Us

Hyperfine Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with theSwoopsystemthe 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 aLead Engineer for Manufacturing and Process Engineeringtosupportthe execution and continuous improvement of our hardware manufacturing and supply chain operations. This role blends hands-on operational leadership with technical manufacturingexpertise 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) andserving as leadfor manufacturing engineering forHyperfineswarehouse drivingprocess optimization initiatives and collaboratingcross-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 Hyperfines 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 areoptimizedfor 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 every day ethos.

Required Education & Experience:

• Bachelors degreein Mechanical Manufacturing IndustrialEngineeringor 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)

Physical Demands:

• This is a full-time on-site position at Hyperfines facility in Guilford CT.
• Travel up to 20% of the time to suppliers contract manufacturers and other sites.
• Available nights weekends and holidays as business needs require.
• Ability to lift up to 50lbs on occasion in both office and production environments (e.g. supportingdevicetransport withappropriate tools)

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.

The annual base salary for this position is between $125000 - $145000. This position is also eligible for to participate in Hyperfines corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set relevant experience qualifications location position level and other job-related reasons.

Agency Resumes: We do not accept resumes from recruitment agencies. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.