Scientist I/II, Engineering - Design Verification Engineer

BioSpace

North Chicago (IL)

On-site

USD 95,000 - 135,000

Full time

9 hours ago

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Benefits offered by this job

Comprehensive benefits including PTO

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie in North Chicago, IL, is seeking an experienced Scientist I/II, Engineering Design Verification Engineer to join the Combination Product Development & Drug Delivery Team to advance new drug/device products.

You will work with engineering and biopharmaceuticals on design verification, data analysis, and method development, with cross-functional collaboration across Quality, Regulatory, Clinical, and global partners.

Qualifications

Bachelor's or higher in mechanical/biomedical engineering; 5+ years in pharma/medical devices.
Experience with design verification, testing protocols, and regulatory standards (FDA/ISO).
Familiarity with cGMP, GDP, and document control practices.

Responsibilities

Lead development of lab capabilities for Design Verification testing.
Support equipment/software qualification, SOPs, and training.
Develop test methods and perform data analysis and reporting.
Operate and verify use of Zwick or similar machines.
Collaborate across Quality, Regulatory, Clinical, and global partners.

Skills

Lab data analysis

Cross-functional collaboration

Good communication

Statistical methods

Minitab experience

Education

Bachelor's Degree in Mechanical or Biomedical Engineering

Master's Degree or equivalent

Tools

SolidWorks

Polarian ELN

Zwick Universal Test Machine

GMP/Design Controls familiarity

3D printing

Job 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

Job Description

We are looking for an experienced Scientist I/II, 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 Scientist I/II, 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

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 and work instructions, resolving issues, training operators, and representing combination product development on cross-functionally validated systems.
Support 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

Scientist I, Engineering:Bachelors Degree in Mechanical or Biomedical engineering or equivalent education andtypically 5+ years of experience, MastersDegree or equivalent education and typically 2+years of experience.
Scientist II, Engineering:Bachelors Degree in Mechanical or Biomedical engineering or equivalent education and typically 7+ years of experience, MastersDegree or equivalent education and typically 5+years of experience.
3+ years of experience in pharmaceutical or medical device/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

Experience and understanding of development and verification of complex combination products such as On-Body-Delivery-Devices and continuous pumps
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

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,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.Compensation is measured, based off experience and the level of the position.
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 toparticipate in our short-term incentiveprograms.Note: No amount of payis considered to bewages or compensation until such amount isearned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthatare allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole andabsolute 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, visithttps://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

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