23 days old

Senior Principal Device Engineer

Company Info
Job Description

 

The Sr. Principal Device Engineer, Combination Product and Device is responsible for design, development, implementation, and analysis of medical devices as well as serving as SME for sustaining engineering for products manufactured at the site. 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. Expected to lead and participate in site-wide initiatives. Expected to present to senior management as required.  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.

 

Essential Duties:

  • Lead, coordinate and participate in 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. 
  • Review design output documentation such as component and assembly drawings utilizing SolidWorks, bill of materials generation, tolerance analyses, FEA and Flow Simulation reports 
  • 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. 
  • Review Risk Management File documents including User FMEA, Design FMEA, Process FMEA and material selection rational for biocompatibility. 
  • 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. 
  • Serve as SME for sustaining engineering of products manufactured on site. Review and approve change controls, propose and implement design changes, create and execute protocols for design verification, and lead changes to design history files. 
  • Follows Teva Safety, Health, and Environmental policies and procedures.
Qualifications

 

Minimum Qualifications:

  • Bachelor's degree in Mechanical, Chemical or Biomedical Engineering or equivalent field of study
  • 5+ years of experience developing medical devices or combination products

 

Preferred Qualifications:

  • Master's degree
  • Knowledge of regulatory and standard guidelines such as: 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.
  • Able to direct the work of junior group members and prototype technicians
  • Experience working on multiple projects with aggressive timelines
  • Strong presentation and communication skills
Function
Sub Function
Reports To

Associate Director, Global Device R&D Operations

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Categories

Posted: 2020-07-21 Expires: 2020-09-12

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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Senior Principal Device Engineer

Teva Pharmaceuticals

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