Teva Pharmaceuticals USA, Inc.

Device Development Engineer

Location US-PA-West Chester
Requisition #
18-20779
# Positions
1
Experience (Years)
5
Category
Research & Development - Biopharmaceutics

Overview

As a Device Development Engineer in Teva's West Chester R&D Devices group, you will be responsible for the design, development, verification and validation of combination products in support of Teva’s global R&D pipeline with special focus on delivery of biologics.  You will apply your knowledge of the regulations, directives, guidelines and standards relevant to the combination products on which you contribute. Your breadth of engineering expertise, knowledge and practices will be applied to creatively solve complex problems. You will contribute as part of a global team of biologics and combination products developers who are motivated by the opportunity to have a positive impact on patient’s lives. 

Responsibilities

Responsibilities:

  • Author and/or contribute to product requirements, specifications, verification and validation plans and reports and other design history file documentation as required.
  • Oversee and/or develop mechanical designs to realize technical solutions to meet product, testing and research needs, producing high quality specifications.
  • Design and develop robust test protocols to challenge product performance while ensuring adherence to applicable standards.
  • Develop and execute feasibility testing in support of product development.
  • As a “Hands on” engineer you may lead the development of rapid prototype models, design fixtures, participate in small quantity builds as required, and execute testing.
  • Work with suppliers to ensure that their designs and processes meet the requirements for Teva.  Perform assessments of their designs and deliverables for quality, robustness and safety, leading suppliers to improve performance where necessary.
  • Ensure that every product in your care is robust in design; you will perform engineering analysis and routinely provide evidence of robustness, reliability and efficacy.
  • Lead or assess safety risk management activities and define the critical components of the design.
  • Create and review and approve technical drawings, reports, data and other documents.
  • Ensure compliance with Teva’s Quality Management System.
  • Support the creation and management of robust project plans.
  • Author sections of regulatory filings.

PLANNING, ORGANIZING & CONTROLLING

  • Generate device and equipment ideas and concepts
  • Preparation of ‘Invention disclosures’
  • Perform risk analysis, FMEA etc.
  • Support the design of and build of product prototypes using CAD and rapid prototyping tools
  • Apply mathematic and engineering principles to create mechanisms and component parts.
  • Collect, calculate and interpret data from experiments
  • Facilitate IQ, OQ and PQ equipment and process qualifications
  • Perform product and process root cause analysis and problem solving
  • Review detailed design for assembly and manufacture of product
  • Verify and validate device designs
  • Implement transfer of design to manufacture
  • Occasional travel to locations where activity is current
  • Perform key ‘scheduled product development’ reviews at stages defined in the company’s design control system
  • Perform product and process root cause analysis and problem solving
  • Create and maintain documentation and design history according with Teva design and quality control system, ensuring compliance to relevant standards and regulations.
  • Other duties may be assigned by department management.

Qualifications

Requirements

  • BS/MS in Mechanical, Biomedical or other related Engineering discipline, and 5-10 years relevant experience
  • Current knowledge of and deep experience in the selection and/or design and commercialization of drug delivery devices in the Biotech industry.
  • Deep understanding of Primary Packaging requirements for biologics.
  • Strong working knowledge of current standards and regulatory expectations for injection device and combination product development, filing and commercialization.
  • Experience with device manufacturing and assembly processes, failure analysis, stress analysis, DFM, rapid prototyping, hands on engineering, materials testing, Inspection and measurements
  • Experience in creation and review of technical drawings, documents and reports.
  • Competent in the use of statistical methods, Tolerance Analysis, GD&T (geometric dimensioning and tolerancing)
  • Preferred Proficient in the use of Solidworks 3D CAD and MS Office Suite, Minitab
  • Ability to work in a global team environment.

 

Travel Requirements:  Ability to travel globally - approximately 25% or as per project requirements.

 

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