Job Description

About the Role

Our Company's Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused engineer focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products). This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company's pipeline to identify risks (i.e. when/why/how will the device fail) and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device's material and functional properties and attributes.

Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically though mechanical (i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Our Company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our Company's Research Laboratories is a true scientific research facility of tomorrow and will take our Company's leading discovery capabilities and world-class small molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Education Requirement

• Minimum: B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field

Required Experience and Skills

• A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience
• Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting
• Experience training junior staff on instrumentation operation and data analysis/interpretation best practices
• Deep technical understanding of test method development and qualification/validation/transfer techniques
• Fluency with mechanical testing, imaging, and measurement equipment and techniques, including, but not limited to:
• Force/tension/compression testing
  • Rhinometry
  • Microscopy
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing
• Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis
• Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes

Preferred Experience and Skills

• Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, and drop shape analyzers
• Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans
• Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle
• Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
• Familiarity with the following standards:
• Quality Management – ISO 13485
  • Risk Management – ISO 14971
  • EU MDR
  • Medical Electrical Equipment – EN 60601
  • Medical Device Software Standard – IEC 62304
  • ISO 11608 Needle-based injection system for medical use
• Additional familiarity/experience with the following industry related knowledge is a plus:
• 21 CFR Part 4
  • 21 CFR 211
  • FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics
  • ISO 13485
  • ISO 14971
  • ISO 11040
  • ISO 10993
  • ISO 11608

Required Skills

• Accountability
• Analytical Method Development
• Creativity
• Data Analysis
• Electromechanical Engineering
• EU MDD
• External Partners
• Geometric Dimensioning And Tolerancing (GD&T)
• ISO 13485 Medical Devices
• Manufacturing Processes
• Mechanical Design
• Mechanical Engineering
• Mechanical Testing
• Medical Devices
• Medical Devices Design
• Medical Software
• Method Validation
• Microscopies
• Parasitology
• Product Development
• Prototyping
• Quality Management
• Rheometry
• Statistical Analysis

Compensation and Benefits

• Salary Range: $117,000.00 - $184,200.00
• Eligible for annual bonus and long-term incentive, if applicable
• Comprehensive package of benefits including medical, dental, vision coverage

Work Model

• U.S. Hybrid Work Model effective September 5, 2023: Employees in office-based positions in the U.S. will work a hybrid schedule consisting of three total days on-site per week, Monday
• Thursday, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

This Hybrid work model does not apply to:

• Field-based positions
• Facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site
• Positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work)
• Any other position for which the Company has determined the job requirements cannot be reasonably met working remotely
• Roles designated as "remote"

Application

• Current Employees apply HERE
• Current Contingent Workers apply HERE

Equal Opportunity Employment

US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

• EEOC Know Your Rights
• EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts.