- Teleflex (Wyomissing, PA)
- …* Minimum of 3 years of previous experience in related field (eg medical device design and manufacturing, or similar regulated industry, plastic processing, ... for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design. * Understanding of verification...and FDA 21 CFR 820) and quality standards for medical devices . * Understanding of design verification… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally...as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
- Globus Medical, Inc. (Audubon, PA)
- …0-3 years of experience in product development or sustaining engineering within the medical device industry. + Proficiency with **CAD software (CREO or ... Qualifications** + Internship or co-op experience in a regulated industry, ideally medical devices . + Exposure to post-market surveillance activities or… 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. +...14971 highly desirable). + Experience with FDA 510K cleared medical devices and has contributed to 510K… more
- Omnicell (Pittsburgh, PA)
- …field, with prior experience in a leadership role + Strong understanding of medical device design, regulatory processes, system integration, and standards ... creation and maintenance of documentation, and ensuring compliance with relevant medical device regulations + Other duties include troubleshooting, mentoring,… more
- Medtronic (Pittsburgh, PA)
- …understanding of regulatory requirements and industry standards governing medical device reprocessing. + Excellent communication, interpersonal, and ... Standards such as St-79, 58, and other pertaining to medical devices reprocessed in hospital settings. **Nice...upholding the highest standards of safety and quality in medical device reprocessing. + This position is… more