Senior Manufacturing Engineer

Hyperfine·
Guilford, Connecticut
3mo ago
SeniorHardwareNeurologyMay Not Sponsor
$125K - $145K/yr(estimated)

Description

<p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>About Us</strong></span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the <em>Swoop<sup><sub>®</sub></sup> </em>system—the 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. <a href="https://hyperfine.io/" target="_blank">Learn More</a></span></p> <hr> <p style="line-height: 1;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>About The Role</strong></span></p> <p style="line-height: 1;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><span style="text-decoration: underline;">Job Title</span><strong>: </strong>Senior Manufacturing Engineer</span></p> <p style="line-height: 1;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><span style="text-decoration: underline;">Location</span>:<strong> </strong>Guilford, CT, USA</span></p> <p><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">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.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":0}"> </span></span></p> <p><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">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.</span><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":0}"> </span></span></p> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>Key Responsibilities:</strong></span></p> <p><span style="text-decoration: underline; font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Manufacturing & Operations Oversight</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Manage day-to-day production activities in coordination with contract manufacturers (CMs) to meet quality, delivery, and cost targets.</span> </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Oversee Hyperfine’s warehouse operations, ensuring efficient material flow, inventory accuracy, and compliance with storage and handling requirements. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Partner with Logistics, Quality, and Finance to ensure smooth end-to-end operations from production through shipment. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Track and report on key manufacturing KPIs such as yield, throughput, and cost performance.<span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></li> </ul> <p><span style="text-decoration: underline; font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Process & Quality Engineering</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Lead “design for manufacturability” efforts with R&D to ensure products are optimized for scalable production.</span> </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Develop and maintain process documentation including SOPs, work instructions, and process control plans. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Implement continuous improvement initiatives to reduce cost, improve yield, and strengthen process reliability. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Support troubleshooting and root cause analysis for manufacturing issues, coordinating with both internal teams and external partners. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Review and approve Engineering Change Orders (ECOs) for impact to materials, processes, and obsolescence.<span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></li> </ul> <p><span style="text-decoration: underline; font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Supplier & Partner Management</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Serve as the primary operations liaison with contract manufacturers and key suppliers.</span> </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Evaluate supplier performance and partner on corrective actions to achieve cost, quality, and delivery goals. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Support supplier selection, equipment evaluation, and process capability reviews.<span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></li> </ul> <p><span style="text-decoration: underline; font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Cross-Functional Collaboration</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span data-contrast="none">Work closely with Quality, R&D, and Service teams to ensure manufacturing alignment with product design and regulatory standards (FDA, ISO 13485).</span> </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;" data-leveltext="" data-font="Symbol" data-listid="11" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Collaborate with Finance and Supply Chain to support cost forecasting, inventory planning, and operational efficiency initiatives.<span data-ccp-props="{"134233117":false,"134233118":false,"335551550":0,"335551620":0,"335559738":240,"335559739":240}"> </span></span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>Knowledge, Skill & Abilities:</strong></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Communication Skills – Excellent written communication and verbal communication skills for interacting with diverse teams, stakeholders, and external partners.</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">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.</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Analytical Skills – Ability to analyze data, identify trends, and make data-driven decisions</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Collaboration – Effectively collaborate and influence stakeholders from a variety of different disciplines to build positive, cross-functional relationship that foster teamwork</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Organization Skills – Strong organizational skills with attention to detail and the ability to manage and prioritize multiple competing priorities.</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Adaptable – Able to thrive in a dynamic, fast-paced virtual environment.</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">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.</span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>Required Education & Experience:</strong></span></p> <ul> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering or related field (or equivalent experience)  </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">5-8 years of experience in a manufacturing operations or manufacturing engineering role, ideally within a regulated industry (medical device).  </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Proven track record managing contract manufacturers and/or in-house production operations. </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Experience developing and maintaining manufacturing documents under quality system requirements (FDA, ISO). </span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;">Experience with ERP systems (e.g., NetSuite) and data-driven process improvement methods (Lean, Six Sigma, SPC)<span data-ccp-props="{"335559738":0,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </span></span></li> </ul> <p><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><strong>Physical Demands:</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">This is a full-time, on-site position at Hyperfine’s facility in Guilford, CT.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">Travel up to 20% of the time to suppliers, contract manufacturers, and other sites.</span></li> <li style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">Available nights, weekends, and holidays as business needs require.</span></li> <li style="font-family: helvetica, arial, sans-serif; font-size: 10pt;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">Ability to lift up to 50lbs on occasion in both office and production environments (e.g., <span class="TextRun SCXW33037732 BCX0" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW33037732 BCX0">supporting </span><span class="NormalTextRun SCXW33037732 BCX0">device </span><span class="NormalTextRun SCXW33037732 BCX0">transport with </span><span class="NormalTextRun SCXW33037732 BCX0">appropriate tools</span><span class="NormalTextRun SCXW33037732 BCX0">)</span></span><span class="EOP SCXW33037732 BCX0" data-ccp-props="{"335559738":0}"> </span></span></li> </ul> <p><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><em>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.</em></span></p> <p><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><em>The annual base salary for this position is between $125,000 - $145,000. This position is also eligible for 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.</em></span></p> <hr> <p><span style="font-size: 10pt; font-family: helvetica, arial, sans-serif;"><em>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.</em></span></p>
Hyperfine

Hyperfine

BIOTECHNOLOGY

Portable MRI Scanner

LocationCT - Guilford
Open Jobs9
NeurologyOncology
View Company Profile

Pipeline

Swoop Plus Mk2.0N/A
Portable MRI acquisitionN/A
Evaluation of Gadolinium Based Contrast AgentsN/A