- Envista Holdings Corporation (Quakertown, PA)
- …solution development as well as enhancement of existing software components + Software development in an FDA -regulated industry + Experience working within a ... the leading manufacturer and distributor of innovative dental imaging equipment, software , and solutions. We offer meaningful work through innovation, diverse… more
- Globus Medical, Inc. (Audubon, PA)
- …lives as quickly as possible. **Position Summary:** As a Group Manager of Software , you will be responsible for planning, managing and implementing all aspects of ... a software activities of a small software team... craftsmanship, and test-driven development. + Understanding of an FDA design control environment. + Supports manufacturing, internal testing,… more
- Insight Global (Murrysville, PA)
- Job Description We are looking for a mid-level Embedded Software Test Engineer to join a close-knit test team at one of our largest medical device clients. These ... streamlined solutions Perform code reviews with focus on quality, FDA standards, compatibility, and security. Analyze test results and...Part 820, IEC 62304, ISO 13485) for medical device software development is a plus. Experience with privacy and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Job Description** We're looking for a Principal Software Engineer to join our growing team and lead the development and strategy for our Digital Medicine ... high-performance, scalable, data-centric, serverless microservices + Own and deliver software architecture, diagrams, design documents + Primary engineering lead,… more
- RELX INC (Horsham, PA)
- Director of Research and Software Engineering Are you ready for a leading role? Would you enjoy working on our cutting-edge products? About Us At LexisNexis Reed ... concepts. About the Role The Director of Research & Software Engineering will lead the development of our regulated...ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives… more
- Eliassen Group (Harrisburg, PA)
- ** Software Engineer** **Anywhere** **Type:** Contract-to-Hire **Category:** Development **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN ... Jobs **Description:** Our client is hiring for an iOS Software Engineer to join their team in San Diego,...PLUS: Bluetooth experience & Any industry experience that has FDA requirements OR enterprise level company experience and documentation.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, ... as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is… more
- Guthrie (Sayre, PA)
- …direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 years of experience in managing a ... Operations & Compliance + Deep understanding of human-subjects research compliance (AAHRPP, FDA , IRB, GCP, ICH). + Experience in integrating clinical research into… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …+ Prepare, submit and coordinate the process validation requirements for non-product software validations + Participates in the FDA premarket approval process ... that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... product development . Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project...and develops instruments and implants using Creo and SolidWorks software . Partners with in-house prototype shop and outside… more