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SMTC Corporation
9 hours ago

Quality Engineer

NewBe an early applicant North America
United States

SMTC is hiring for a Quality Engineer! SMTC Corporation was founded in 1985. SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and…

As9100 Corrective Action ERP FMEA Iso 13485 +7 skills
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EPTAM Precision Solutions
9 hours ago

Machinist A - 1st Shift (Sign-on bonus)

NewBe an early applicant North America
United States

EPTAM Precision | Northfield, NH is looking for a Class A Machinist - 1st Shift to join our team. This position is eligible for a $3,000 sign-on bonus! Join us as we create devices being used in all facets of the…

Cnc Design for Manufacturing (DFM) FMEA Iso 13485
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EPTAM Precision Solutions
9 hours ago

Machinist A - 1st Shift (Sign-on bonus)

NewBe an early applicant North America
United States

EPTAM Precision | Northfield, NH is looking for a Class A Machinist - 1st Shift to join our team. This position is eligible for a $3,000 sign-on bonus! Join us as we create devices being used in all facets of the…

Cnc Design for Manufacturing (DFM) FMEA Iso 13485
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Tekni-Plex
13 hours ago

Operations Quality Engineer

NewBe an early applicant North AmericaFull-time
United States

Imagine: A Career with Purpose and Possibility Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact…

Corrective Action Iso 13485 Root Cause Analysis
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XVIVO
14 views 14 hours ago

Field Service Engineer

Open 56d On-siteNorth America
United States

XVIVO is seeking a highly motivated Field Service Engineer to support our growing installed base of advanced medical devices across North America. This role is responsible for installation, preventive maintenance,…

Iso 13485 Regulatory Compliance Salesforce SAP
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Clarius Mobile Health
12 views 14 hours ago

Senior Regulatory Specialist, AI/ML Projects

Open 56d RemoteNorth AmericaContractSenior
Canada

Regulatory Specialist on a two-year fixed-term contract, supporting Clarius's Data Science and Regulatory Affairs teams. Day to day: writing DHF and technical documentation for AI/ML-enabled ultrasound/SaMD devices, documenting ML models, datasets and performance metrics, and preparing FDA 510(k), Health Canada and EU MDR submissions.

AI CAD Cloud Data Science Iso 13485 +2 skills
85K – 105K CAD
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Sekisui Diagnostics
15 hours ago

QA Specialist

NewBe an early applicant North AmericaFull-time
United States

Are you passionate about quality, compliance, and finding practical solutions in a regulated environment? We’re looking for a QA Specialist who can bring strong Quality Systems knowledge, sound judgment, and a…

Iso 13485
Apptronik
8 views 15 hours ago

Senior Business Systems Manager

Open 23d North 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

Apptronik is a human-centered robotics company developing AI-powered robots to support humanity in every facet of life. Our flagship humanoid robot, Apollo, is built to collaborate thoughtfully with people, starting…

Agile AI Altium Analytics API +22 skills
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MARLIN STEEL WIRE PRODUCTS
16 hours ago

TIG Welder / Fabricator - 2nd shift

NewBe an early applicant North America
United States

Shift hours: Monday through Thursday, 3:30pm - 2:00am Marlin Steel Wire Products is seeking a skilled TIG Welder/Fabricator to support custom, high‑volume stainless steel and wire assembly production. This role…

Iso 13485 Iso 9001
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VDyne
16 hours ago

Principal Design Assurance Engineer

NewBe an early applicant North AmericaPrincipal
United States

THE ROLE As Principal Design Assurance Engineer at VDYNE, you'll serve as a senior Quality representative embedded in our cross-functional product development teams, ensuring that design controls, risk management,…

Acceptance Criteria Iso 13485
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Boston Scientific
16 hours ago

Senior Supplier Quality Engineer - Direct Materials Acquisitions

NewBe an early applicant On-siteNorth AmericaSenior
United States

Recruiter: Spencer Gregory Hale Sr. Supplier Quality Engineer – Direct Materials Acquisitions About the role: The Global Sourcing organization at Boston Scientific is a global, passionate team that oversees a diverse…

Corrective Action Iso 13485
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Tekni-Plex
16 hours ago

Sr Quality Manager

NewBe an early applicant North AmericaFull-timeSenior
United States

Imagine: A Career with Purpose and Possibility Picture this: You are part of a global team of problem-solvers whose innovations in materials science can make life better. Every day, you help turn ideas into impact…

Iso 13485 Performance Management Root Cause Analysis Six Sigma Statistics
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Ascential Technologies
17 hours ago

Program Manager

NewBe an early applicant North AmericaFull-time
United States

Program Manager who leads medical device development programs end-to-end—planning, schedules, phase-gate and design reviews, risk and budget tracking, and client reporting—on-site in Corvallis, Oregon, working within FDA/ISO 13485 design controls, with exposure to 3D printing and data center projects.

Iso 13485 Program Management
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RR Donnelley
17 hours ago

Manager, Quality Assurance & Regulatory Affairs

NewBe an early applicant North AmericaFull-time
United States

Manages the Quality Management System and regulatory affairs for RR Donnelley's Houston site, covering medical device, pharma, and food manufacturing. Day to day: leading QA staff, audits, CAPAs, process validation, software quality, and compliance with ISO 13485, ISO 14971, FDA QSR, and eQMS systems.

Iso 13485 Root Cause Analysis
107K – 171K $
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HeartFlow
11 views 17 hours ago

Test Architect

Open 22d North AmericaContractMiddle 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

Senior individual contributor and founding technical hire on Heartflow's Test Engineering team, architecting end-to-end automated testing, AI-first test automation, post-deployment verification, and tool validation for regulated SaMD cardiac imaging software. Core stack includes Selenium, Playwright, API testing tools, CI/CD, AWS, and medical device QMS practices.

AI API Automation AWS CI/CD +25 skills
190K – 250K $
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HeartFlow
13 views 17 hours ago

Senior Test Engineer

Open 60d North AmericaContractSenior 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

The Senior Test Engineer will design and maintain automated end-to-end test suites for HeartFlow's AI-driven medical software, ensuring compliance with regulated medical device standards. The role involves leading automation strategy, mentoring team members, and collaborating with cross-functional teams to validate clinical computation services and 3D visualization tools.

AI API API Testing Automation AWS +26 skills
165K – 205K $
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HeartFlow
6 views 17 hours ago

Senior Systems Engineer

Open 19d HybridNorth AmericaSenior 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

Senior Systems Engineer at HeartFlow, a medical technology company building AI-driven cardiac diagnostics (FFRCT coronary analysis) in San Francisco (4+ days in office). The role owns system-level requirements, functional architecture, traceability, risk management, and V&V strategy for medical device software under IEC 62304, leading cross-functional engineering, quality, and regulatory efforts.

AI Automation Corrective Action Cybersecurity Iso 13485 +7 skills
180K – 215K $
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Everware Consulting GmbH
18 hours ago

Senior Microsoft Dynamics 365 Business Systems Analyst – Manufacturing & Supply Chain

NewBe an early applicant North AmericaFull-timeSenior
United States

Senior business systems analyst focused on Microsoft Dynamics 365 Finance & Operations ERP for manufacturing and supply chain. Day to day: gathering requirements from business teams, configuring and testing the ERP, managing data quality and change requests, and coordinating with internal users and external implementation partners.

Agile Cloud Data Quality ERP Iso 13485 +9 skills
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iRhythm
18 hours ago

Senior Director, Global Infrastructure Technology & Operations

Open 20d RemoteNorth AmericaContractSenior
United States

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere…

AI Analytics Automation AWS Azure +44 skills
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AirLife
18 hours ago

International Warehouse Manager

NewBe an early applicant North AmericaContract
United States

COMPANY DESCRIPTION At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to…

Corrective Action ERP Iso 13485 OSHA Performance Management +2 skills
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