Teva Pharmaceuticals USA, Inc.

Principal Mechanical Engineer

Location US-UT-Salt Lake City
Requisition #
18-20738
# Positions
1
Experience (Years)
15
Category
Engineering - Mechanical Engineering

Overview

Position Summary:  

The Principal Mechanical Engineer is responsible for design, development, implementation, and analysis of medical devices. Performs engineering design evaluations. May develop a range of products. Recommends alterations to development and design to improve quality of products and/or procedures. Identifies functional problems and suggests resolutions. Complies with applicable quality systems, medical device regulations and pharmaceutical regulations. Works under minimal supervision and is expected to be able to lead the work of other more junior engineers as well as technicians. Coordinates their work with Teva Device Design Centers, Teva Drug-Device Project Teams and manufacturing sites, Contract Development Organization (CDO) or Contract Manufacturing Organization for feasibility, device development and design control activities.

 

Responsibilities

Essential Duties & Responsibilities:

 

Execute/participate in/coordinate R&D development activities such as design of prototypes, design of experiments, design of test fixtures, perform testing activities, draft experimental protocols and reports. Perform product and process root cause analysis and problem solving.
Generate/review design output documentation such as component and assembly drawings utilizing SolidWorks, bill of materials generation, tolerance analyses, FEA and Flow Simulation reports
Execute/review product commercialization activities such as design or assembly, part and cost reduction including interfacing with the device manufacturer, component suppliers, and assembly equipment vendors.
Generate/review Risk Management File documents including User FMEA, Design FMEA, Process FMEA and material selection rational for biocompatibility.
Generate, execute, and/or review Design Verification protocols as well as write technical reports. Must have a working knowledge of statistics including determination of sample size, design of experiments and ANOVA.
Implement transfer of design to manufacture of product. Generate/review manufacturing documentation such as assembly work instruction, validation protocols and reports, batch records, and IQ OQ PQ equipment qualifications.

Qualifications



Position Requirements:

Education:

-       Identify the minimum education that would typically be required / preferred to perform this position

-       Requirements should include course of study, degree level, and major/field of study

Required:

Bachelor of Science in Mechanical or Biomedical Engineering

Preferred:

Master Degree in same

Experience:

-       Identify the minimum years of experience that would be required / preferred for a candidate to enter this position

-       Include the type of experience, any specialty skill experience, and/or supervisory/managerial experience required / preferred

Required:

  • Pharmaceutical / Medical Device industry experience with 15+ years of experience developing medical devices.
  • Strong presentation and communication skills.
  • Ability to work on multiple projects with aggressive timelines.
  • Works independently, without daily direction and direct the work of junior group members and prototype technicians.
  • Speak fluent English

Preferred:

  • Injection Devices

Company / Industry Related Knowledge:

Moderate knowledge of all relevant regulatory guidelines and standards (e.g. 21CFR820.30, 21CFR part 4, ISO 13485, IEC60601, ISO 14971, ISO 20072, ISO 10993, ANSI/AAMI HE75, MDD 93/42/EEC, and FDA/EMEA guidance documents.

 



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