- AMETEK.Inc (Mansfield, MA)
- …required by clients. Requires adherence to Good Manufacturing Practices (GMP) and FDA , ISO, and environmental requirements and must adhere to safety guidelines and ... operations with medical devices. + Knowledge and experience with GMP, ISO, FDA , and quality standards + Experience with manufacturing documentation such as, but… more
- Medtronic (Billerica, MA)
- …biomedical/medical device industry. Navigates various government and industry regulations to include FDA Quality System Regulation 21 CRF 820 and ISO 9001, ISO ... systems such as ProShop, or SAP manufacturing systems. Coordinates FMEA, validation , methodical problem solving, product design & manufacturing engineering. Utilizes… more
- Nanobiosym, Inc. (Cambridge, MA)
- …well as with external notified bodies and third parties including CLIA, FDA and other global regulatory authorities. Position Responsibilities * Maintain Licensure ... expectations. * Ensure the timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and… more
- Nanobiosym, Inc. (Cambridge, MA)
- …lifecycle: Specification, architecture, circuit design, simulation, schematic capture, prototyping, validation , and release to manufacturing. + Lead PCB design and ... hardware and driver requirements. + Design and build test fixtures for hardware validation and functional testing. + Support regulatory and quality processes with a… more
- ConvaTec (Lexington, MA)
- …authorities + Oversee, provide guidance, and if necessary, write and submit US FDA submissions, including 510(k)s, De Novo, etc, and EU MDR Technical Documentation, ... currently marketed product portfolio + Review, interpret and communicate FDA /EU/international regulations and guidance documents to ensure complete and… more
- Nestle (Waltham, MA)
- …unique opportunity to apply GMP principles to an area as yet unregulated by the FDA . Our unique product provides the opportunity to grow within a cutting edge GMP ... Operation, and Performance Qualification and Requalification Protocols. * Administrate the Validation Management platform and schedule validation events with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive ... key technical role is responsible for change controls, manufacturing process validation , device product complaints, regular review of DHF, and post-market… more
- Philips (Cambridge, MA)
- …focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing lean tools- 6S, ... processes to ensure accurate and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools. **You're the right fit if:** +… more
- Medtronic (Beverly, MA)
- …ensure knowledge sharing across shifts. + Complete documentation in compliance with FDA regulations and Good Manufacturing Practices (GMP) and adhere to safety ... Qualifications:** + Experience in medical device, pharmaceutical, or other FDA -regulated industries + Experience maintaining **plastics processing equipment (extrusion)**… more
- Globus Medical, Inc. (Methuen, MA)
- …+ Develop and execute verification plans, protocols, and reports in compliance with FDA , ISO 13485, and other regulatory standards. + Design and develop various ... Engineering, or a related field + Proven experience in hardware verification or validation in the medical device, robotics or Defense industry with a minimum of… more
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