What are the responsibilities and job description for the Product Specialist position at United Pharma Technologies Inc?
Job Title: Product Development Specialist
Location: Pennsylvania (PA)
Position Summary:
We are seeking an experienced Product Development Specialist with a strong background in medical device sterilization to support product lifecycle activities. This role will focus on sterilization processes, validation, and collaboration with external manufacturing partners to ensure product quality and regulatory compliance.
Key Responsibilities:
- Lead and support radiation sterilization activities, including dose mapping and validation
- Develop and execute cleaning validation protocols and reports in compliance with regulatory standards
- Collaborate with external manufacturers and suppliers to ensure proper process execution and quality outcomes
- Provide technical expertise in sterilization methods and ensure alignment with industry standards
- Support product development, process improvements, and troubleshooting related to sterilization and cleaning
- Ensure compliance with FDA, ISO, and GMP requirements
Required Qualifications:
- 5–10 years of experience in medical device product development or sterilization
- Hands-on experience with radiation sterilization and dose mapping
- Strong knowledge of cleaning validation processes
- Experience working with contract manufacturers and external suppliers
- Familiarity with regulatory requirements for medical devices (FDA, ISO standards)
- Strong problem-solving and cross-functional collaboration skills