Senior Manufacturing Engineer

Senior Manufacturing Engineer

Location:

Guilford, CT, USA

Function:
Engineering and Information Technology

Hyperfine, Inc. (Nasdaq: HYPR) is a groundbreaking health technology company redefining brain imaging with the Swoop® system—the first FDA‑cleared, portable, ultra‑low‑field magnetic resonance brain imaging system. Our mission is to revolutionize patient care globally through accessible, clinically relevant diagnostic imaging.

Hyperfine is seeking a Senior Manufacturing Engineer 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.

• Manage day‑to‑day production activities with contract manufacturers to meet quality, delivery, and cost targets.
• Oversee 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 optimize products 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 internal teams and external partners.
• Review and approve Engineering Change Orders (ECOs) for impacts 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.

• Excellent written and verbal communication skills for interacting with diverse teams and stakeholders.
• Knowledge of all aspects of medical device design, verification and validation, process validation, and design transfer to manufacturing.
• Analytical skills to analyze data, identify trends, and make data‑driven decisions.
• Strong collaboration and influence skills, fostering cross‑functional teamwork.
• Organizational skills with attention to detail and ability to prioritize multiple competing priorities.
• Adaptability in a dynamic, fast‑paced virtual environment.
• Self‑motivation and a commitment to continuous improvement and integrity.

• 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 documentation under quality system requirements (FDA, ISO).
• Experience with ERP systems (e.g., Net Suite) and data‑driven process improvement methods (Lean, Six Sigma, SPC).

• Full‑time, on‑site position at Hyperfine’s facility in Guilford, CT.
• Travel up to 20% of the time to suppliers, contract manufacturers, and other sites.
• Availability nights, weekends, and holidays as business needs require.
• Ability to lift up to 50 lbs on occasion in both office and production environments.

Applicants must be authorized to work for any employer in the U.S. We are not able to sponsor or take over sponsorship of any employment…