Design Verification Engineer - Method Development

Design Verification Engineer - Method Development

AbbVie

Ludwigshafen, Germany

Job Description

We are looking for an experienced Design Verification Engineer – Method Development (all genders) to join our Device and Combination Product Development to contribute to the development of exciting new drug/device combination products.

Your tasks and responsibilities

• Subject Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer.
• Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.
• Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Utilize Zwick Universal Test Machine (UTM) and other GMP and non-GMP test equipment used for combination product development and Design Verification.
• Software Tools: Utilize Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian.
• Implementing process automation and digitalization initiatives to enhance efficiency and reliability in device development and manufacturing processes.
• Utilizing analytical modelling for key performance attributes and ensuring compliance with regulatory requirements, including FDA, EMA, and ISO standards.

Qualifications

• Bachelor Degree or equivalent education with typically 7 or more years of experience or Master Degree or equivalent education with typically 5 or more years of experience. 5+ years of experience in medical devices or combination products.
• Proficiency and knowledge in the design and testing of injection devices and combination products.
• Comprehensive background in operating and maintaining material testing equipment
• Strong communication skills (both written and verbal) including the ability to influence without direct authority.
• Knowledge of ICH and ISO Guidelines, GMP, Design Controls, GDP, and FDA regulations.
• Documentation experience including technical reports, design verification plans, protocols, etc.
• Strong understanding of engineering fundamentals with strong problem solving and analytical skills.
• A keen eye for identifying project risks and proactively developing mitigation plans.
• Self-driver with proven track record of actively engaging and working in a matrixed environment with cross-functional teams, strong decision making, and completing quality deliverables on time.