Product Development Specialist jobs in United States
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United Pharma Technologies Inc · 7 hours ago

Product Development Specialist

positionPennsylvania, United States
timeContract
remoteOnsite
senioritySenior Level
date5+ years exp

United Pharma Technologies Inc is seeking an experienced Senior Sterilization & Product Development Specialist to support medical device development activities. The role emphasizes radiation sterilization, dose mapping, and cleaning validation while collaborating closely with internal teams and external manufacturing partners.

BiotechnologyData ManagementHealth CareMedicalPharmaceutical
Hiring Manager
Hemasundar Annam
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Responsibilities

Lead and support medical device sterilization activities, including radiation sterilization (gamma and/or e-beam)
Perform and review radiation dose mapping and dose substantiation
Develop and execute cleaning validation protocols and reports
Collaborate with external manufacturers, CMOs, and suppliers
Support product development, process changes, and design transfer activities
Ensure compliance with FDA, ISO, and medical device quality standards
Troubleshoot sterilization and validation-related issues

Qualification

Medical device sterilizationRadiation sterilizationDose mappingCleaning validationISO 13485FDA QSRCollaboration with manufacturersDocumentation skillsCommunication skills

Required

5–10+ years of experience in medical device product development or validation
Hands-on experience with: Medical device sterilization
Hands-on experience with: Radiation sterilization & dose mapping
Hands-on experience with: Cleaning validation
Experience working with external manufacturers and suppliers
Strong documentation and cross-functional communication skills

Preferred

Bachelor's degree in Engineering, Life Sciences, or related field
Familiarity with ISO 11137, ISO 13485, FDA QSR (21 CFR 820)

Company

United Pharma Technologies Inc

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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.
dateFounded in 2010
location
South Plainfield, New Jersey, USA
people-size201-500 employees
web-link
https://unitedpharma.us/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2022-07-18Acquired

Leadership Team

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Babjee M
Founder/ Srategic Partner
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Company data provided by crunchbase