ProPharma · 6 hours ago
Process Engineer (Med Device)
Raleigh, NC
Part-time
Hybrid
Mid LevelProPharma is a company that has been enhancing health and wellness for over 20 years by partnering with biotech, med device, and pharmaceutical organizations. They are seeking a Process Engineer to provide technical guidance and support for FDA 510(k) submissions, including drafting necessary documentation and specifications.
BiopharmaMedicalPharmaceutical
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
Draft study plans, protocols and reports to support their FDA 510(k) submission for their First Mixed Flow Axial ECMO Platform
Generate product technical specifications
Support testing of the device
Perform qualifications
Define manufacturing layout for optimal process performance
Provide overall guidance
Qualification
Required
Technical knowledge transfer and 510(k) readiness
Experience in process engineering within the medical device industry
Ability to draft study plans, protocols, and reports
Experience with FDA 510(k) submissions
Ability to generate product technical specifications
Experience in supporting testing of medical devices
Experience in performing qualifications
Ability to define manufacturing layout for optimal process performance
Strong communication skills for virtual and onsite meetings
Ability to work in a hybrid environment with travel to Northern California site
Company
ProPharma
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market.
Founded in 2001
1001-5000 employees
H1B Sponsorship
ProPharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (6)
2022 (4)
Funding
Current Stage
Late StageTotal Funding
$8.63MKey Investors
Jump Capital
2020-10-23Series Unknown· $8.63M
2020-09-22Acquired
2015-03-25Series Unknown
Leadership Team
Dawn Sherman
CEO and Board Chair
Brian Tuttle
Chief Financial Officer
Recent News
2025-12-11
2025-12-05
Company data provided by crunchbase