[Remote] Process Engineer (Med Device)

Note: The job is a remote job and is open to candidates in USA. ProPharma 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 virtually and onsite to support engineering teams
• Provide process engineering guidance
• Review materials provided by the client
• Draft documentation to support quality 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 optimal process performance
• Provide overall guidance Skills
• Technical knowledge transfer and 510(k) readiness
• Experience in process engineering guidance
• Ability to review materials provided by the client
• Experience in drafting documentation to support quality 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 optimal process performance Company Overview
• At ProPharma, 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
• ProPharma has a track 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