United Pharma Technologies Inc · 19 hours ago
Design History File Documentation Consultant
New Jersey, United States
Contract
Onsite
Senior Level
5+ years expUnited Pharma Technologies Inc is seeking experienced DHF Documentation Consultants to support medical device design and development activities. This role will focus on the creation, remediation, and maintenance of Design History File (DHF) documentation in compliance with FDA and applicable regulatory standards.
BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
Responsibilities
Develop, review, and remediate Design History File (DHF) documentation in accordance with FDA 21 CFR 820 and ISO 13485
Create and update Design FMEA (DFMEA) and Risk Management (FMEA) documentation
Support 510(k) submissions by preparing and aligning design documentation
Review and interpret engineering drawings and specifications, including GD&T (Geometric Dimensioning & Tolerancing)
Ensure traceability between design inputs, outputs, verification, and validation
Collaborate with R&D, Quality, Regulatory, and Manufacturing teams
Support internal and external audits related to design controls and DHF content
Qualification
Required
5–10 years of experience in medical device documentation or design controls
Strong hands-on experience with DHF documentation
Proven experience with DFMEA and FMEA
Solid understanding of GD&T
Direct experience supporting FDA 510(k) submissions
Strong knowledge of FDA design control requirements and ISO standards
Excellent documentation, communication, and organizational skills
Preferred
Experience in DHF remediation or audit response
Background in regulated medical device environments
Ability to work independently and manage multiple documentation streams
Company
United Pharma Technologies Inc
United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
201-500 employees
H1B Sponsorship
United Pharma Technologies Inc 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 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Growth StageTotal Funding
unknown2022-07-18Acquired
Leadership Team
Babjee M
Founder/ Srategic Partner
Company data provided by crunchbase