- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... The Lead Project Engineer (PE) oversees all technical aspects of Synapse product implementation, from solution validation phases through product go-live.. Lead… more
- RELX INC (Horsham, PA)
- …You'll guide a small team of engineers and work side-by-side with a senior product manager to define, build, and iterate on early-stage concepts. About the ... ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives...autonomy, innovation, and rapid iteration. + Collaborate with the product manager to shape roadmaps, scope experiments,… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... well as completion of study related activities including but not limited to regulatory submissions, data entry, and regulatory compliance visits. + Assure… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... II (Tier II) handles remote technical support across our product lines for HCUS customers. The expectation of the...level of success with yearly goals provided by your manager and metrics defined on a team level. +… more
- PCI Pharma Services (Philadelphia, PA)
- …+ Primary Key Performance Indicators (KPI) are On Time Equipment Commissioning and Product Launch; Project Cost Performance; Product Launch Quality and Cost ... new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... 1) provides highly visible remote technical support across our product lines for HCUS customers. This role focuses on...level of success with yearly goals provided by your manager and metrics defined on a team level. +… more
- Omnicell (Pittsburgh, PA)
- …experience in a leadership role + Strong understanding of medical device design, regulatory processes, system integration, and standards like FDA QSR and ISO ... integrating various engineering disciplines, and ensuring compliance with stringent regulatory and quality standards. You will collaborate with cross-functional… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... This role provides onsite, hands-on client support for Fujifilm Endoscopy's entire product catalog. This role provides education and training to Company personnel… more
- PCI Pharma Services (Philadelphia, PA)
- …Road, Philadelphia Department: Engineering Shift: First Shift Reporting To: Sr. Manager Process Engineering & Continuous Improvement Responsible For (Staff): _Yes_ ... (eg, Lean, Six Sigma) to enhance productivity, eliminate waste, and improve product quality. + Lead and coordinate engineering projects, ensuring alignment with… more