- Leidos (Pittsburgh, PA)
- …models, finite element modeling, and other simulation tools for device modeling, sensor network development, and instrumentation automation. Publications in ... a week, and 1 day a week from home office. Primary Responsibilities: + Design , simulate, and optimize Surface Acoustic Wave (SAW) devices based on sensing stimuli of… more
- Philips (Murrysville, PA)
- …evolving medical product safety regulations and guidelines, offering input into the design and execution of safety studies and vigilance activities to ensure ... in areas such as Medical/Clinical Affairs/Medical Safety in the Medical Device industry strongly preferred. Prior bedside Respiratory Therapist experience is… more
- Wolters Kluwer (Philadelphia, PA)
- …role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering teams to operate ... mitigation activities, including timeline,resource,and budgetary risksthat arise during the device lifecycleto ensure business priorities are met. Support device… more
- Globus Medical, Inc. (Eagleville, PA)
- …wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus' ... timely release of subassemblies and assemblies by executing, reviewing and approving Device History Records (DHRs) and ERP transactions per internal requirements +… more
- Oracle (Harrisburg, PA)
- …and operational requirements to establish best practices for managing security for every device in our data centers. A security-focused engineer at any level can ... of cloud usage. + Provide consulting and review of device sanitization as per NIST-800-88 R1 standards. + Provide...industry + Consult development teams and third-party vendors in design and architecture of secure systems. + Champion and… more
- Globus Medical, Inc. (Limerick, PA)
- …wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus' ... and polishing and blending machined surfaces of the medical device (s). The job requires the individual to be a...and polishing and blending machined surfaces of the medical device (s). * **Assembler I:** entry level role, deburring of… more
- Teleflex (Wyomissing, PA)
- …to support 510(k)s, Canada License applications, European Union (EU) Medical Device Regulations (MDR) submissions, and other regulatory deliverables, take primary ... Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc. * Support regulatory… more
- Merck (West Point, PA)
- …work in support of Centers of Excellence for the packaging and device community including logistics and distribution technologies, small molecule bulk and primary ... including supply chain, packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, to facilitate effective COE support… more
- West Pharmaceutical Services (Exton, PA)
- …requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and safety system product ... + Minimum 5 years of relevant experience + 2+ years of medical device regulatory experience preferred + Experience with US FDA regulations (Title 21CFR820), EU… more
- Philips (New Kensington, PA)
- …will develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, with a primary focus on Software ... as a Medical Device (SaMD) for our Sleep & Respiratory Care products...international regulatory submissions. + Participate in strategic product development, design solutions starting from concept phase to product delivery… more