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Merck

Makes medicines, vaccines and animal treatments

Associate Principal Scientist/Engineer - Medical Device and Combination Products, Analytical

Biomedical Engineering & Medical DevicesPosted on Nov 10
Full-timeWest Point, PA, USA

About the Job

Requirements

  • A Ph.D. in Mechanical, Chemical, or Biomedical Engineering, or an equivalent field, is required.
  • A minimum of three years of experience with a Ph.D. in a role responsible for medical device or combination product development verification, method development, and testing is required.
  • Experience with mechanical testing, imaging, and measurement equipment and techniques is required, including tensile, compression, and torsional testing; materials characterization; X-ray computed tomography; rheometry; and microscopy.
  • The role requires collaboration and leadership skills to work as part of cross-functional teams to meet project timelines and deliverables.
  • Required skills include analytical chemistry, computed tomography, cross-cultural awareness, design validations, design verification, design verification testing, device characterization, interdisciplinary collaboration, materials characterization, mechanical testing, medical devices engineering, microscopies, professional networking, rheometry, tensile strength testing, tomography, and X-ray imaging.

Responsibilities

  • Act as an analytical lead for one or more medical device and combination product projects.
  • Lead cross-functional working groups to develop and own an analytical strategy that satisfies Design Controls inputs and to manage the associated timeline and analytical efforts.
  • Develop and validate mechanical test methods for device characterization and formal design verification.
  • Coordinate and provide technical oversight for internal staff or external laboratory testing as needed to meet project timelines and deliverables.
  • Provide technical coaching.

Desired Qualifications

  • Experience developing innovative device characterization and design verification strategies and mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols, with appropriate selection of acceptance criteria.
  • Experience with medical device development and understanding or familiarity with Design Controls (21 CFR 820.30) and relevant industry standards.
  • Prior hands-on analytical experience with medical devices and combination products and Design Controls is ideal.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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