Scientist I/II, Engineering - Design Verification Engineer

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

We are looking for an experienced Scientist I/II, Engineering Design Verification Engineer to join our Combination Product Development & Drug Delivery Team and contribute to the development of new drug/device combination products. This role sits at the intersection of engineering and biopharmaceuticals within a multi-disciplinary team.

Responsibilities

• Lead development of lab capabilities, including GMP and non-GMP equipment, software, and data-acquisition systems for Design Verification testing.
• Support equipment and software qualification, SOPs, work instructions, issue resolution, operator training, and represent combination-product development on cross-functionally validated systems.
• Support lab verification activities: design-verification protocol development, test-method development, test execution, data analysis, documentation, and report writing; assist with investigations and issue resolution; present results to cross-functional teams.
• Operate volumetric-accuracy equipment and force-testing machines; familiarity with Zwick, viscometers, climate chambers, etc. is a plus.
• Perform data analysis using statistics; experience with Minitab is a plus.
• Develop, validate, and transfer test methods.
• Use machine-shop equipment, SolidWorks, and 3D printers to design and verify test-method fixtures.
• Work independently under the guidance of a supervisor or technical lead.
• Comply with applicable policies, procedures, regulatory, and safety requirements.
• Collaborate on cross-functional teams including Quality, Regulatory Affairs, Clinical Team, and global partners.

Qualifications

• Scientist I, Engineering: Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent) and typically 5+ years of experience; or Master’s degree (or equivalent) and typically 2+ years of experience.
• Scientist II, Engineering: Bachelor’s degree in Mechanical or Biomedical Engineering (or equivalent) and typically 7+ years of experience; or Master’s degree (or equivalent) and typically 5+ years of experience.
• 3+ years of experience in pharmaceutical or medical-device/combination products.
• Experience with design control, risk management, and regulatory standards including ISO compliance, FDA, ASTM standards, and regulatory knowledge.
• Knowledge of Good Manufacturing Practices (GMP), Design Controls, Good Documentation Practices (GDP), and FDA regulations.

Preferred Qualifications

• Experience developing and verifying complex combination products such as on-body delivery devices and continuous pumps.
• Hands-on experience with Universal Test Machines (UTM), preferably Zwick.
• Strong written and verbal communication skills; ability to influence without direct authority and present to auditors on equipment qualification and data integrity.
• Familiarity with regulated device-testing processes, including detailed verification and validation methodologies.
• Documentation experience including technical reports, design-verification plans, and protocols.
• Strong engineering fundamentals, problem-solving, and analytical skills.
• Basic statistics and Six Sigma techniques are a plus.
• Self-driven with a proven track record of engaging in matrixed environments, making sound decisions, and delivering quality work on time.

Pay

The base-pay range for this role is determined by job grade and considers factors such as geographic location, experience, and level. Individual compensation may vary within the posted range.

Benefits

• Paid time off (vacation, holidays, sick leave).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.