Process Engineer (Med Device) jobs in United States
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ProPharma · 11 hours ago

Process Engineer (Med Device)

positionUnited States
timeFull-time
remoteRemote
seniorityMid Level

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.

BiopharmaMedicalPharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Process engineeringFDA 510(k) submissionTechnical specificationsManufacturing layoutCollaboration

Required

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

ProPharma

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At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market.
dateFounded in 2001
location
Overland Park, Kansas, USA
people-size1001-5000 employees
web-link
http://www.propharmagroup.com/

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 Stage
Total Funding
$8.63M
Key Investors
Jump Capital
2020-10-23Series Unknown· $8.63M
2020-09-22Acquired
2015-03-25Series Unknown

Leadership Team

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Dawn Sherman
CEO and Board Chair
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Brian Tuttle
Chief Financial Officer
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Recent News

PR Newswire
Cell and Gene Therapy Market to Exceed US$105B by 2033, Driving Strategic Value Across Healthcare Portfolios | According to DataM Intelligence
2025-12-29
prnasia.com
ProPharma Expands Operations with New Office in Hyderabad
2025-12-11
PR Newswire
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
2025-12-05
Company data provided by crunchbase