- Globus Medical, Inc. (Audubon, PA)
- …engineering within the medical device industry. + Proficiency with **CAD software (CREO or SolidWorks preferred)** for mechanical design and documentation. + ... post-market surveillance activities or complaint handling systems. + Understanding of ISO 13485, FDA 21 CFR Part 820, or EU MDR regulations. **Why Join Globus… more
- GE HealthCare (State College, PA)
- …related discipline. + Must be competent using SolidWorks or equivalent design software .. + Statistically sound data analysis abilities to describe, diagnose, predict ... a manufacturing environment through employment or internships. + Experience in a FDA , ISO13485, or other highly regulated environment preferred. + Demonstrable use… more
- J&J Family of Companies (West Chester, PA)
- …to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions. + Contributes to ... Knowledge of GDP (Good Documentation Practice) is preferred. + Knowledge of CAD software (eg ProE/ Creo) is preferred. + Knowledge of various types of manufacturing… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Kelly Services (Fort Washington, PA)
- …All training is to be completed within the specified timelines. + Interact with FDA or in-house inspectors during audits as needed. + Maintain a safe work ... to be sent. Transcribe shipping request form information into the FedEx/DHL or other software to generate shipping labels. + Track and maintain a record of all… more
- Fujifilm (Harrisburg, PA)
- …and providing our customers with timely responses. + Works on 3rd party hardware, software , and network related issues that are sold or supported by FUJIFILM. + ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Penn Medicine (Philadelphia, PA)
- …and privacy. Ensure compliance with relevant and evolving regulations (eg HIPAA, coming FDA regulations). + Team Management: Lead, mentor, and grow a team of data ... scientists, machine learning engineers, and software developers. Set high performance expectations and help team to achieve them. Create a positive culture that… more
- Penn Medicine (Philadelphia, PA)
- …Board of Pharmacy, USP <795>, <797>, and <800>, the Joint Commission, FDA , and OSHA. Assists leadership in maintaining employee education and learning files. ... which includes scheduling with appropriate trainers, documentation within scheduling software , and communication between all parties. -Delivers training on specific… more