• Sr Supply Chain Planner

    Terumo Medical Corporation (Somerset, NJ)
    …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...and Quality Systems standards and specifically with FDA Quality System Regulation and EN46000. +… more
    Terumo Medical Corporation (07/09/25)
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  • Nobel Biocare Process Development Engineer…

    Envista Holdings Corporation (Mahwah, NJ)
    …machining with 5-axis CNC milling machines and related manufacturing processes in a medical device environment. + 3+ years in a manufacturing engineering or ... documents that will be reviewed and audited by the FDA . + Assist the Quality team as...process development role within a regulated industry, preferably medical devices. + Experience with Process Failure Mode Effects… more
    Envista Holdings Corporation (07/12/25)
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  • Principal Software Engineer - Cloud

    Otsuka America Pharmaceutical Inc. (Trenton, NJ)
    …in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... commitment to collaborative problem solving, sophisticated design, and the creation of quality products are essential. Your team's primary focus is building core… more
    Otsuka America Pharmaceutical Inc. (08/08/25)
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  • Cardiac Monitoring Technician

    ZOLL Medical Corporation (Parsippany, NJ)
    …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
    ZOLL Medical Corporation (08/23/25)
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  • Supervisor, Production - Weekend (Friday - Sunday)

    Integra LifeSciences (Plainsboro, NJ)
    …all established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + ... (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes...gowning. + Batch manufacturing experience. + Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National… more
    Integra LifeSciences (07/08/25)
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  • Validation Engineer II

    Integra LifeSciences (Plainsboro, NJ)
    …experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment. + Demonstrates excellent organizational and ... a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the… more
    Integra LifeSciences (07/22/25)
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  • Internal Auditor, Regulatory Compliance

    Integra LifeSciences (Plainsboro, NJ)
    …knowledge of auditing techniques. + Minimum of 3-5 years of Medical Device , Pharmaceutical or related experience, preferably in FDA regulated industry. + ... or more of the following areas: + Manufacturing of medical devices, pharmaceutical API, or drug products, Facilities, Engineering,...Experience with the application of FDA and/or ISO Quality System Requirements. +… more
    Integra LifeSciences (06/14/25)
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  • Associate Director, Regulatory Affairs

    United Therapeutics (Trenton, NJ)
    …daughter's pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... ), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans… more
    United Therapeutics (08/10/25)
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  • Assoc Endoscopic Repair Tech

    Fujifilm (Wayne, NJ)
    …and procedures. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard ... or degree preferred, but will consider applicants with repair experience in electronics, medical device , mechanical, or a similar field. + Soldering experience… more
    Fujifilm (08/16/25)
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  • Associate Director, Technical Solutions

    BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
    …technical field required; _Master's degree preferred_ + Expert-level proficiency in ISO 13485, Medical Device Regulation (MDR), and FDA requirements with ... ISO frameworks, GMP/GDP protocols, and USP-EP guidelines as they apply to medical device environments + Demonstrated capability to align technical decisions… more
    BD (Becton, Dickinson and Company) (08/08/25)
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