Senior Design Verification Engineer

Senior Scientist I, Engineering – Design Verification Engineer

We are looking for an experienced Senior Scientist I, Engineering – Design Verification Engineer to join our Combination Product Development & Drug Delivery Team to contribute to the development of exciting new drug / device combination products.

As a Senior Scientist I, Engineering – Design Verification Engineer you would be part of a multi-disciplinary team of professionals working at the intersection of engineering and biopharmaceuticals. If you are a self-motivated & communicative person who thrives on solving complex problems and are excited by the idea of taking on the toughest health challenges, this opportunity might be for you.

Responsibilities

• Serve as Subject Matter Expert (SME) on lab capabilities, including GMP and non-GMP equipment, software, and data acquisition systems for Design Verification testing.
• Responsible for equipment and software qualification, SOPs and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.
• Lead lab verification activities, including design verification protocol development, test method development, test execution, data analysis and documentation, and report writing. Support investigations and issue resolutions. Present results to cross-functional teams.
• Utilize volumetric accuracy equipment and force testing machine. Familiarity with Zwick, viscometers, climate chambers, etc. is a plus.
• Support data analysis using statistics, experience with Mini Tab is a plus.
• Develop, validate, and transfer test methods.
• Utilize machine shop equipment, Solid Works, and 3D printers to design and verify test method fixtures.
• Experience with Solid Works, Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred.
• Work in an independent manner under the guidance of a supervisor or technical lead.
• Comply with applicable policies and procedures, regulatory and safety requirements.
• Work on cross-functional teams including Quality, Regulatory Affairs, Clinical Team, and global partners.

Qualifications

• Bachelor's Degree or equivalent education and typically 10+ years of experience, Master's Degree or equivalent education and typically 8+ years of experience, PhD and no industry experience necessary.
• 3+ years of experience in medical device or combination products
• Experience with design control, risk management, and regulatory standards including ISO compliance, FDA and ASTM standards, and regulatory knowledge.
• Knowledge of Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations.
• Possess thorough theoretical and practical understanding of own scientific discipline.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.