- Teleflex (Wayne, PA)
- … FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... Medical Director, Interventional Urology and Urology Care (REMOTE)...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
- Insight Global (Murrysville, PA)
- …Software Test Engineer to join a close-knit test team at one of our largest medical device clients. These testers will be responsible for ensuring the quality ... drive streamlined solutions Perform code reviews with focus on quality , FDA standards, compatibility, and security. Analyze...21 CFR Part 820, IEC 62304, ISO 13485) for medical device software development is a plus.… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …in applying FDA design control requirements (21 CFR ) as applied to medical device software and medical device regulation (IEC-62304) ... commitment to collaborative problem solving, sophisticated design, and the creation of quality products are essential. Your team's primary focus is building core… more
- Globus Medical, Inc. (Audubon, PA)
- …+ 1-3 years of mechanical design engineering experience preferably in the medical device field + Bachelor's degree in Mechanical Engineering required. ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- Globus Medical, Inc. (Audubon, PA)
- …following:** + Three to seven years' experience in mechanical design engineering; Medical device experience strongly preferred + Bachelor's Degree in Mechanical ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
- Envista Holdings Corporation (Quakertown, PA)
- …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster ... as needed. **PREFERRED QUALIFICATIONS:** + MS degree preferred. + Medical device design and compliance experience. +...Engineering documentation (ISO 14971 highly desirable). + Experience with FDA 510K cleared medical devices and has… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …perform Evaluation, functional testing, basic troubleshooting, and service new or used medical devices according to procedure with high quality standards, within ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more