Hyperfine | AI-Powered Portable MRI
Senior Manufacturing Engineer
Hyperfine | AI-Powered Portable MRI, Guilford, Connecticut, us, 06437
Senior Manufacturing Engineer
Location: Guilford, CT, USA
Function: Engineering and Information Technology
About the Company 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.
About the Role 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.
Key Responsibilities
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.
Knowledge, Skill & Abilities
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.
Required Education & Experience
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., NetSuite) and data‑driven process improvement methods (Lean, Six Sigma, SPC).
Physical Demands
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.
Application Information 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 visa now or in the future.
The annual base salary for this position is between $125,000 and $145,000. This position is also eligible to participate in Hyperfine's 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.
Seniority Level Mid‑Senior Level
Employment Type Contract
Job Function Engineering and Information Technology
Industries Medical Equipment Manufacturing
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Function: Engineering and Information Technology
About the Company 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.
About the Role 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.
Key Responsibilities
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.
Knowledge, Skill & Abilities
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.
Required Education & Experience
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., NetSuite) and data‑driven process improvement methods (Lean, Six Sigma, SPC).
Physical Demands
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.
Application Information 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 visa now or in the future.
The annual base salary for this position is between $125,000 and $145,000. This position is also eligible to participate in Hyperfine's 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.
Seniority Level Mid‑Senior Level
Employment Type Contract
Job Function Engineering and Information Technology
Industries Medical Equipment Manufacturing
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