Beschreibung

As a Senior Process Engineer, you will drive the implementation of next-generation processes for medical devices, ensuring smooth transitions from development to production while optimizing performance and mitigating risks.

Anforderungen

• •B.S. or M.S. in Mechanical, Biomedical, Pharmaceutical Engineering, or related technical discipline
• •7+ years of experience in process engineering within medical device or drug-device combination product development
• •Hands-on expertise in Device Assembly, Final Sterilization, or Final Packaging/Labeling
• •Demonstrated ability to lead technology scaling and New Product Introduction (NPI)
• •Advanced proficiency in statistical data analysis, Quality by Design (QbD), and risk management tools
• •Exceptional communication and negotiation skills

Aufgaben

• •Lead design transfer of medical devices and drug-device combination products
• •Ensure seamless scalability between development and commercial-scale production
• •Utilize Design of Experiments (DoE) to evaluate Critical Process Parameters (CPPs)
• •Conduct Design for Manufacturability, Assembly, and Excellence (DFM/DFA/DFx) assessments
• •Leverage advanced manufacturing technologies for robust process development
• •Define Process Performance Qualification (PPQ) and Quality Control strategies
• •Author and manage risk documentation using FMEA and Tolerance Analysis
• •Lead technical investigations into process deviations or design issues
• •Provide technical oversight for existing products and recommend process enhancements

Tools & Technologien