Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.
Process Development Engineer
Ensures regulatory compliance by completing the appropriate documentation. Contributes to project teams typically including the following activities: research and development, sustaining engineering, design change strategy, test of materials, preparation of specifications, process capability studies, report preparation and test documentation. Serve as subject matter expert for products development. Leads product development to ensure the proposed changes are systematically and thoroughly analyzed to verify that the design intent is still met. Designs and coordinates standard engineering tests and experiments. Performs troubleshooting on products/process problems as related to design, material, or process. Comply with all regulatory and quality systems standard requirements. Prepares, reviews and analyzes appropriate regulatory documentation.
Bachelor’s degree in Engineering related field with 2+ years or more of experience in R&D or similar position.
REQUIREMENTS & SKILLS
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Experience in Process and Equipment Validation
- Validation experience (IQ/SQ/OQ/PQ, Process Characterizations, Test Method Validations) – preferably with knowledge or experience in medical device industry.
- Process development experience or good technical knowledge.
- Knowledge with design controls and risk management within the medical device industry.
- Medical Devices documentation experience (FMEAs, change management, MES, etc)
- Proven ability to work within a regulated industry environment.
- Quality System knowledge.
- Effective communication skills required due to support of cross functional projects within a team.
- Problem Solver
- Fully Bilingual (verbal and written)