Senior Scientist I, Engineering - Design Verification Engineer

AbbVie Inc.; Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) with company match

Short-term incentive programs

Job summary

AbbVie's Combination Product Development & Drug Delivery Team is seeking a Senior Scientist I, Engineering – Design Verification Engineer to advance drug/device combination products. You will work on lab verification, qualification, and cross-functional validation, applying GMP/GDP practices and robust data analysis to ensure compliant, reliable test methods.

You will lead protocol development, test execution, and results reporting while collaborating with Quality, Regulatory Affairs, Clinical,

Qualifications

• Bachelor’s or higher in Mechanical or Biomedical Engineering with extensive related experience.
• 3+ years in medical device or combination products with design control knowledge.
• Familiarity with GMP, GDP, FDA regulations, and ISO standards.

Responsibilities

• Serve as SME on lab capabilities for Design Verification testing.
• Lead qualification, SOPs, and instructional training for operators.
• Develop, execute, and document design verification protocols and tests.
• Analyze data, run statistics, and present results to teams.
• Use SolidWorks and bench equipment to verify test methods.
• Collaborate across Quality, Regulatory Affairs, Clinical, and global partners.

Skills

Lab capabilities

GMP/Non-GMP equipment

Data analysis

Cross-functional teamwork

Test method development

Equipment qualification

Statistical methods

Problem solving

Education

Bachelor’s in Mechanical or Biomedical Engineering

Master’s or PhD (advantage)

Tools

SolidWorks

3D printing

Universal Test Machine (UTM)

Zwick

ELN (Polarian)

MiniTab

Job description

Company Description

About AbbVie

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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 MiniTab is a plus.
• Develop, validate, and transfer test methods.
• Utilize machine shop equipment, SolidWorks, and 3D printers to design and verify test method fixtures.
• Experience with SolidWorks, 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 in Mechanical or Biomedical engineering or equivalent education and10+ years of experience, Master’sDegree or equivalent education and typically 8+years of experience, PhD and 0+ years of exp.
• 3+ years of experience in medical device or combination products is required. 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.

Preferred Qualifications

• Significant experience and understanding of development and verification of complex combination products such as On-Body-Delivery-Devices and continuous pumps
• Significant experience with operation and maintenance of a Universal Test Machine (UTM), preferably Zwick
• Strong communication skills (both written and verbal) including the ability to influence without direct authority and ability to present to auditors on equipment qualification and data integrity.
• Regulated device testing processes, including detailed verification and validation methodologies. Documentation experience including technical reports, design verification plans, protocols, etc.
• Strong understanding of engineering fundamentals with strong problem solving and analytical skills.
• Knowledge in basic statistics and Six Sigma statistical techniques is a plus.
• 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html