- West Pharmaceutical Services (Exton, PA)
- …the time. **Additional Requirements** + Ability to comprehend principles of math, science, engineering , and medical device use. + Ability to handle technical ... for CE Marking, technical packages. The Sr. Specialist ensures timely and high- quality execution of all regulatory deliverables. In addition, the Sr. Specialist… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …(Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been ... manufacturing drawings, inspection instructions, wiring diagrams or schematics and engineering change notices. + Position involves basic measurement equipment… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …(Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been ... manufacturing drawings, inspection instructions, wiring diagrams or schematics and engineering change notices. + Position involves basic measurement equipment… more
- Deloitte (Philadelphia, PA)
- IIOT Engineer (Senior Consultant/Specialist Senior) AI & Engineering Join our AI & Engineering team in transforming technology platforms, driving innovation, and ... our clients' success. You'll work alongside talented professionals reimagining and re- engineering operations and processes that are critical to businesses. Your… more
- Oracle (Harrisburg, PA)
- …data exchanges between kiosk hardware and enterprise platforms. + Own the quality and accuracy of supporting materials, including device standards, installation ... and scalable processes. + Serve as the escalation authority for device performance, software/firmware issues, and field incidents. + Author roadmaps, investment… more
- Envista Holdings Corporation (Quakertown, PA)
- …+ Collaboration with cross functional teams: mechanical engineering , software engineering , quality engineering , regulatory affairs. + Has developed ... has a growing, energetic, and diverse mix of professionals spanning engineering , operations, regulatory and quality backgrounds that work collaboratively… more
- Wolters Kluwer (Philadelphia, PA)
- …responsible for creating and managing the software development plan and partnering with engineering , quality , and regulatory team members to aligning the process ... the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling...The Principal SaMD TPM acts as a bridge between engineering , product, regulatory affairs, clinical, and quality … more
- Teleflex (Wyomissing, PA)
- …and technical writing. * Actively participate in cross-functional teams (Regulatory, Quality , Clinical, Marketing, Procurement, Process Engineering ) to ensure ... method development, optimization, and validation. * Demonstrated experience working within quality -regulated environments (FDA, ISO standards) in medical device ,… more
- Kelly Services (Horsham, PA)
- …, Intake, Medical Safety, Quality External and Internal Sites, PQM Quality Engineering , etc. to ensure comprehensive, cohesive and consistent process ... will be responsible for documenting and reviewing malfunction medical device reporting MDR data fields and assisting with end-to-end...+ Provides leadership and support in execution of the quality role in the MDR process for combination products.… more
- Oracle (Harrisburg, PA)
- …Health Data Intelligence is entering a high-impact phase of **MDR (Medical Device Regulation)** readiness and **regulatory transformation** . Over the next year, HDI ... a large volume of **technical documentation, risk management activities, and engineering design updates** required for compliance across our AI-enabled population… more