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Designs and optimizes purified water systems, chemical formulation processes, and sanitary fluid handling equipment for clinical diagnostic reagent manufacturing in a regulated cGMP/ISO environment.
Ensures compliance and market access for diagnostic solutions by managing regulatory submissions, maintaining registrations, and supporting quality systems under global standards like FDA and EU IVDR.
Ensures medical devices meet regulatory standards by preparing documentation, coordinating submissions, and advising on compliance for agencies like ANMAT in Argentina.
Principal Design Assurance Engineer at Medtronic leads design verification and risk management for life-saving medical devices, ensuring regulatory compliance and robust product development in interventional cardiology.
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva , one of Danaher’s 15+ operating companies, our work saves…
Senior Procurement Specialist at BD manages raw material purchases for medical device manufacturing, negotiates supplier contracts, and ensures supply chain efficiency using SAP and ISO 13485 standards.
Verification and Validation Engineer at Vital Bio, responsible for designing and executing test plans for medical device development, working with R&D and Engineering teams on design verification and validation activities. The role involves hands-on testing with electrical equipment (oscilloscopes, multimeters, signal generators), developing automated test tools using Python and MATLAB, and ensuri
Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness…
The Quality & Regulatory Affairs Department provides strategic leadership, governance, and oversight for Integrated Medical Systems' quality systems, regulatory compliance, and continuous improvement…
Responsible for ISO 13485/AS9100 quality systems, leading CAPA and MRB processes, and supporting precision machining manufacturing with data analytics and inspection plans.
At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical…
Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people,…
Manages supplier qualification and Production Part Approval Process (PPAP) for medical device components, ensuring quality and regulatory compliance using MasterControl.
Manages supplier quality for medical device compliance, working with FDA 21 CFR Part 820, ISO 13485, EU MDR regulations. Day-to-day includes supplier audits, SCAR management, quality agreements, and SAP data governance. Key technologies: SAP, PPAP/FAI documentation review, and quality tools like FMEA and 8D.
Business Development Manager MedTech Unser Kunde zählt zu den führenden Systemlieferanten für hochpräzise Komponenten und mechanische Baugruppen in der Medizintechnik. Zu den Kunden zählen internationale Hersteller und…
Technical Key Account Manager Medizintechnik Unser Kunde zählt zu den führenden Systemlieferanten für hochpräzise Komponenten und mechanische Baugruppen in der Medizintechnik. Zu den Kunden zählen internationale…
Strategic Account Manager MedTech Unser Kunde zählt zu den führenden Systemlieferanten für hochpräzise Komponenten und mechanische Baugruppen in der Medizintechnik. Zu den Kunden zählen internationale Hersteller und…
Senior Key Account Manager Medizintechnik Unser Kunde zählt zu den führenden Systemlieferanten für hochpräzise Komponenten und mechanische Baugruppen in der Medizintechnik. Zu den Kunden zählen internationale…
Designs and builds proprietary manufacturing equipment for surgical robot systems, taking ownership of components like kinematics, robotic actuation, and sensing solutions. Uses SolidWorks CAD, integrates mechatronics (sensors, motors, pneumatics, motion/vision control), and applies quality tools like Cpk and Gauge R&R to ensure product reliability in a medical device manufacturing environment.
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