Site Engineering Technology Expert I

Teva Pharmaceutical Industries West Chester , PA 19380

Posted 11 months ago

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

As a Senior Device Development Engineer in Teva's West Chester R&D Devices group, you will be responsible for the early device feasibility testing, design functionality, 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 engineering knowledge along with 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 combination products developers who are motivated by the opportunity to have a positive impact on patient's lives.

Responsibilities:

  • Develop and execute feasibility testing in support of product development. Create comprehensive feasibility performance plans and reports for new devices. 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.

  • As a "Hands on" engineer you may lead the design and development of rapid prototype models for new devices, generate device and equipment ideas and concepts, design fixtures, participate in small quantity builds, execute testing, create, review and approve technical drawings, reports, data and other documents. Perform engineering analysis, conduct or review DFM/DFA assessments, and routinely provide evidence of robustness, reliability and efficacy.

  • Oversee and/or develop mechanical designs to realize technical solutions to meet product, testing and research needs, producing high quality specifications.

  • Support the design of and build of product prototypes using CAD and rapid prototyping tools, and Apply mathematic and engineering principles to predict and analyze device design performance including thru simulations and tolerance analysis. Collect, calculate and interpret data from experiments

  • Author and/or contribute to the development and execution of product requirements, specifications, verification and validation plans, testing, and reports and other design history file activities as required including design reviews. Lead or assess safety risk management activities and define the critical components of the design. Perform risk analysis, FMEA, product and process root cause analysis and problem solving etc. Support the creation and management of robust project plans.

  • Create and maintain documentation and design history according with Teva design and quality control system, ensuring compliance to relevant standards and regulations.

Qualifications

Requirements:
BS/MS in Mechanical, Biomedical or other related Engineering discipline, and min. 10 years directly relevant experience

  • Current knowledge of and experience in the selection and/or design, development, testing, and commercialization of drug delivery devices in the biotech or medical industry.

  • Experience in early device concept/product development including concept design and robustness testing.

  • Understanding of Primary Packaging requirements for biologics including testing methods for demonstrating CCI.

  • 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 larger global team environment.

Travel Requirements:
Ability to travel globally - approximately 15% or as per project requirements.

Function

Engineering

Sub Function

Engineering

Reports To

Associate Dir R&D Unit, Device R&D

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Nearest Major Market: Philadelphia


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Site Engineering Technology Expert I

Teva Pharmaceutical Industries