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Hyperfine
5 views 3 weeks ago

Senior Regulatory Affairs Specialist

Open 79d HybridNorth AmericaSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain…

Iso 13485
Ascom
2 views 3 weeks ago

Senior Software Engineer

Open 19d HybridNorth AmericaSenior
United States

Senior engineer building event-driven, distributed backend systems for clinical alarm management in C#/.NET, integrating HL7 and other protocols in a regulated healthcare environment.

API Automation Azure Cloud C# +15 skills
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3 Key Consulting
1 views 3 weeks ago

Engineer – Biotech Medical Device (Lifecycle Management, Design Controls, Documentation) - (JP15650)

Open 19d HybridNorth AmericaContract H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

A contract medical device engineer specializing in lifecycle management, design controls, and documentation for biotech combination products, focusing on forensic investigations, root cause analysis, and compliance with regulatory standards.

Assembly CAD Gd T Iso 13485 Minitab +3 skills
40 – 46 $ / hr
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3 Key Consulting
2 views 3 weeks ago

Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15626)

Open 19d HybridNorth AmericaContractSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Leads lifecycle management, design control, and CAPA for electromechanical drug delivery devices, including failure analysis, cross-functional collaboration, and regulatory compliance for a biopharmaceutical client.

Iso 13485 Minitab
44 – 48 $ / hr
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3 Key Consulting
1 views 3 weeks ago

Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)

Open 19d HybridNorth AmericaContractSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Senior Device Engineer to manage lifecycle, design control, and CAPA for electromechanical drug-delivery combination products, including failure analysis, supplier collaboration, and regulatory compliance testing.

Iso 13485 Minitab
44 – 48 $ / hr
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3 Key Consulting
3 weeks ago

Principal Device Quality Engineer - IVD devices SME (JP9691-C)

Open 19d MENAContractPrincipal H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
Morocco

Job Title : Principal Device Quality Engineer - IVD devices SME ( JP9691) Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts Employment Type : Contract Business Unit: Digital…

Iso 13485
QRC Group, Inc
3 weeks ago

Validation Engineer

Open 19d LATAM
Puerto Rico

We are seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Hands-on role focused on protocol execution, technical…

Iso 13485 Technical Writing
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RECRUIT EXPRESS PTE LTD
1 views 3 weeks ago

Contract QA Associate (Pharma MNC, West) #HHW

Open 20d APACContract
Singapore

We are seeking a detail-oriented and proactive Associate II, Quality Assurance Compliance to support the implementation and maintenance of the Quality Management System (QMS) at our Singapore site. This role plays a…

Iso 13485
UPS ASIA GROUP PTE. LTD.
3 weeks ago

Healthcare Quality Assurance Manager

Open 18d APAC
Singapore

The Healthcare Quality Assurance (QA) Manager communicates and manages quality policy and objectives and reports on the overall effectiveness of the UPS Healthcare quality program. Job Responsibilities Develop, manage…

Business Development Iso 13485
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PerkinElmer
3 views 3 weeks ago

Senior Product Manager

Open 19d North AmericaSenior H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Leads strategy, roadmap, and go-to-market for a new blood collection and extraction system in life sciences, collaborating with R&D, sales, and marketing to drive adoption and revenue.

Business Development Go-to-Market Iso 13485 Power BI Sales Enablement
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PerkinElmer
3 views 3 weeks ago

Design Assurance Engineer

Open 19d North America H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Leads design assurance for new product development and sustaining engineering in a regulated healthcare tech company, collaborating with R&D, engineering, and manufacturing to ensure compliance, risk management, and process validation for DNA sequencing and drug delivery technologies.

Iso 13485
MatchaTalent
2 views 3 weeks ago

Senior Manufacturing & Quality Engineer – Medical Devices & Consumer Electronics

Open 19d RemoteAPACContractSenior
Malaysia

This role is open to candidates based in Johor Bahru, Kuala Lumpur, or Penang, Malaysia. The position is remote with regional travel as required. Client Overview Our client is a publicly traded healthcare technology…

AI Assembly CAD Computer Vision Embedded Systems +2 skills
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Intuitive Surgical
3 weeks ago

Senior Manager, Advanced Systems Engineering

Open 20d North AmericaFull-timeSenior Licensed UK sponsor — This employer appears on the GOV.UK register of licensed sponsors for the Skilled Worker and related work routes. The licence belongs to the employer and is not a commitment to sponsor this role.H-1B sponsor history — This employer has had H-1B petitions approved by USCIS in the last five fiscal years, per the USCIS H-1B Employer Data Hub. The approval belongs to the employer and is not a commitment to sponsor this role.
United States

Primary Function of Position The Senior Manager, Advanced Systems Engineering is responsible for leading the technical development of a portfolio of advanced energy products at Intuitive. This leader owns the…

Embedded Systems Firmware I2c Iso 13485 Oscilloscope +3 skills
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Ortofon
2 views 3 weeks ago

Ortofon søger to profiler til Quality Assurance: QA-Coordinator og QA-Assistent

Open 15d Europe
Denmark

Vil du være en del af Quality Assurance hos Ortofon? QA-afdelingen søger to nye kolleger – en QA-Coordinator og en QA-Assistent. Begge stillinger har fokus på kvalitet, dokumentation og løbende forbedringer, men med…

Iso 13485
Hilobyaktiia
3 views 3 weeks ago

Data Scientist

Open 20d RemoteEurope
Germany

Analyze clinical and real-world health data to derive insights, build statistical models, and support medical publications and product decisions using Python, SQL, and Spark.

Analytics Bioinformatics CI/CD Data Analytics Data Science +14 skills
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treace
2 views 3 weeks ago

Manufacturing Engineering Manager

Open 20d North America
United States

POSITION SUMMARY: The Manufacturing Engineering Manager is accountable for leading and supporting key strategic projects, new product development, and provides manufacturing oversight. This position act as a subject…

Iso 13485 Process Improvement Six Sigma
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Corin Australia
3 weeks ago

Full-Stack Engineer – C#/React & Azure

Open 20d APACPrincipal
Australia

Build and maintain web apps using C#, .NET, React, and Azure for a robotic and operations platform in Sydney.

API Azure Azure DevOps Azure Functions CI/CD +13 skills
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Xideral
1 views 3 weeks ago

Program Manager – Quality & Compliance Systems - 2847

Open 20d LATAM
Mexico

Lead global quality and compliance programs for a life-sciences company, implementing regulated systems (eQMS, CAPA, deviations, audits) and ensuring adherence to GxP, FDA, and ISO standards.

Agile CRM ERP Iso 13485 ITIL +11 skills
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Cadwell
2 views 3 weeks ago

Product Manager - Intraoperative Neuromonitoring (IONM)

Open 79d RemoteWorldwide
United States

Own the product strategy and roadmap for Cadwell’s intraoperative neuromonitoring (IONM) platform, translating clinical needs into technical specs and guiding global launches of next-gen medical devices.

Acceptance Criteria Agile Azure Azure DevOps DevOps +7 skills
140K – 180K $
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Dot Compliance
2 views 3 weeks ago

QMS Project Manager

Open 20d UK
United Kingdom

Lead end-to-end eQMS implementations for life sciences customers, guiding them through digital quality transformation on a Salesforce-native AI platform.

AI Cloud CRM Iso 13485 PMP +2 skills
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