[Remote] Process Engineer (Med Device)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company that has been enhancing health and wellness for 20 years by offering consulting services to biotech, med device, and pharmaceutical organizations. They are seeking a Process Engineer to support engineering teams with process engineering guidance, documentation for FDA submissions, and overall product specifications. Responsibilities • Attend meetings reputed company and onsite to support engineering teams • reputed company process engineering guidance • Review materials provided by the reputed company • Draft documentation to support reputed company and process deliverables • Drafting study plans, protocols and reports to support their FDA 510(k) submission • Generating product technical specifications • Supporting testing of the device • Performing qualifications • Defining manufacturing layout for reputed company process performance • reputed company overall guidance Skills • Technical knowledge transfer and 510(k) readiness • Experience in process engineering guidance • Ability to review materials provided by the reputed company • Experience in drafting documentation to support reputed company and process deliverables • Ability to draft study plans, protocols, and reports • Experience supporting FDA 510(k) submissions • Ability to generate product technical specifications • Experience supporting testing of medical devices • Experience performing qualifications • Ability to define manufacturing layout for reputed company process performance reputed company • At reputed company, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. It was founded in 2001, and is headquartered in Overland Park, Kansas, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 3 in 2025, 4 in 2024, 6 in 2023, 4 in 2022. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job Apply To this Job