Senior Scientist, Device and Combination Product Test Engineer

Job Description

JOB DESCRIPTION

Our Companys Device Development & Technology (DD&T) Team is seeking a handson/ labfocused engineer focused on the characterization and testing of devices (components subassemblies and full devices) and combination products (drugdelivery products). This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Companys pipeline to identify risks (i.e. when/why/how will the device fail) and opportunities for improvement. They will utilize a wide variety of cuttingedge analytical instruments methods and extensive data analysis/interpretation to build fundamental understanding of the devices 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 electromechanical (i.e. DC motor and battery driving a gearbox) means. Examples include but not limited to injector pens onbody 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 worlds premier most researchintensive biopharmaceutical company. Today were doubling down on this goal. Our Companys Research Laboratories is a true scientific research facility of tomorrow and will take our Companys leading discovery capabilities and worldclass 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 firsthand one of strong ethics & integrity diversified experiences exceptional science and a resounding passion for improving human health. As part of our global team youll 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 is required.

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 techniques.

• Fluency with mechanical testing imaging and measurement equipment and techniques. Including but not limited to force/tension/compression testing rheometry and microscopy.

• Excellent collaboration ideation and prototyping skills including fixture development for functional testing.

• Experience in 3D CAD (e.g. Solidworks) geometric tolerancing and stackup 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 (MSAs) 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 Needlebased 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

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U.S. Hybrid Work Model

Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.

Expected US salary range:

Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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