Principal ScientistEngineer, DrugDevice Combination Products Device Characterization

Job Description

The company Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused technical leader. 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/how will the device fail) and opportunities for this role the successful candidate will utilize a wide variety of cutting-edge analytical instruments and methods including in silico modeling to build fundamental understanding of the devices material and functional properties and attributes. This understanding combined with extensive data analysis/interpretation will allow the role to design and develop functional improvements for these platforms and as the opportunities arise develop new and novel delivery technologies. These drug delivery device technology platforms can be but not limited to pre-filled syringes auto injectors onbody injectors and inhalers. The successful candidate must have effective cross functional collaboration skills demonstrated excellent scientific leadership and superior written and oral communications abilities.

Our company is a global health care leader with a portfolio of prescription medicines vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our companys success is backed by ethical integrity forward momentum and an inspiring mission to achieve new milestones in global healthcare.

Our company is on a quest for cures and is committed to being the worlds premier most research-intensive 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 world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Join us and experience our culture first-hand one of strong ethics & integrity 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):

• Ph.D. with 8 years of industry experience in Mechanical Engineering Biomedical Engineering or an equivalent field is required.

Required Experience and Skills:

• Proven record of scientific accomplishments in combination product development with a strong scientific publication and presentation track record.

• Fluency in structural finite element analysis (FEA).

• Solid testing and troubleshooting skills able to work independently in a laboratory setting

• Expertise with mechanical testing imaging and measurement equipment and techniques. Including but not limited to mechanical testing surface characterization x-ray computed tomography rheometry and microscopy.

• Experience in 3D CAD (e.g. Solidworks) geometric tolerancing and stack-up analysis.

• Fluency in Design Failure Modes and Effect Analysis (FMEA DFMEA).

• Cross-functional communication communicating complex engineering information in laymans terms to facilitate CMC cross-functional understanding and to support project timelines.

• Development experience in risk-oriented regulated environments

• Development project leadership with a proven track record collaborating with and managing external vendors/research partners.

Preferred Experience and Skills:

• 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 ISO 11608 Needle-based injection system for medical use.

• Familiarity with Design Verification (DV) strategies and 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.

• Additional familiarity/experience with the following 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

Required Skills:

Preferred Skills:

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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 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:

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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 anothers thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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