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Senior R&D Mechanical Engineer (Drug Delivery Devices)

Teva Pharmaceuticals


Location:
Washington, PA
Date:
12/14/2017
2017-12-142018-01-12
Job Code:
17-20542
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Job Details

Careers - Teva Pharmaceuticals in the US -Senior R&D Mechanical Engineer (Drug Delivery Devices)

Senior R&D Mechanical Engineer (Drug Delivery Devices)

US-PA-West Chester
Requisition #
17-20542
# Positions
1
Experience (Years)
5
Category
Engineering - Mechanical Engineering

Overview

 

As a Senior R&D Mechanical Engineer in Teva's Innovation Technology Group, working on medical device or combination product development, you will be responsible for the delivery of Mechanical Engineering R&D best practices within Teva’s Global R&D organization.  You will have applied knowledge of the regulations, directives, guidelines and standards relevant to the development of medical devices and combination products. Your breadth of engineering expertise, knowledge and practices will be applied to creatively solve complex problems. You will also have experience in the design of precision mechanisms and plastic injection molded components.  You will be identified as a Subject Matter Expert in mechanical engineering as it relates to medical device and combination product design, both within the Sterile Device Team and other Teva business units.  As such you will also contribute to the development and maintenance of departmental operating systems and processes.

Responsibilities

Responsibilities:

  • Perform in the role of a Design and manufacturing expert for multiple drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle. You will be identified within the business as the primary source of detail engineering knowledge for each device.
  • Work with suppliers to ensure that their designs and processes meet the requirements for Teva.  You will routinely perform assessments of their Engineering 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 design.
  • Develop mechanical designs to realize technical solutions to meet product, testing and research needs, producing high quality specifications, CAD models and detailed 2D drawings with full GD&T.
  • As an “Hands on” engineer you will develop rapid prototype models, build small quantity runs as required.
  • Contribute to product requirements, design history, specifications and verification plans with end-to-end continuity and objectivity.
  • Review technical drawings, reports, data and other documents.
  • Ensure compliance with Teva’s Quality Management System.

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
  • mathematic and engineering principles to create mechanisms and component parts.
  • Collect, calculate and interpret data from experiments
  • Regularly review Intellectual Property landscape
  • Facilitate IQ,OQ and PQ equipment and process qualifications
  • Perform product and process root cause analysis and problem solving
  • Keep abreast of competitor’s devices, related technology, reviewing industry specific journals and periodicals, attending conferences and university technology development.
  • Review detailed design for assembly and manufacture of product
  • Verify and validate device design
  • 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 the company design and quality control system

CONTACT WITH OTHERS 

Internal:

  • Management, Sterile Sites, Innovative and Biosimilar R&D
  • Legal and IP department, Clinical department, Regulatory Affairs, Global Operations, Portfolio and Commercial, Waterford Device R&D Team, Monmouth Junction Device Engineering Team

 External:

  • 3RD Party Device Manufacturers and Suppliers
  • Device Design Consultancy Organizations
  • External Contract Manufacturing Organizations
  • External Specialist Test Houses

Qualifications

BS/MS in Mechanical Engineering

MS and 3-5 years’ experience or BS with 5-8 years’ experience in Mechanical Engineering; Medical device/Combination products experience pred in the pharmaceutical industry.

 

Training in ISO 13485 Design Controls, ISO 14971 medical device risk management and European Medical Device Directive/Regulations

 

Experience in design for medical device development, manufacturing and assembly processes, failure analysis, stress analysis, DFM, DFSS, high volume manufacturing processes, rapid prototyping, hands on engineering, materials testing, Inspection and measurements

 

Experience in Quality engineering, reviewing of technical drawings, documents and reports

 

Competent in the use of statistical methods, Tolerance Analysis GD&T (geometric dimensioning and tolerancing)

 

Proficient in the use of Solidworks 3D CAD, MS Office Suite, MS Project, simulation and Minitab

 

Ability to work in a global team environment.

 

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Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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