The Sr. Device Development Engineer is responsible for design, development, implementation, and analysis of medical devices. Performs engineering design evaluations of devices from assigned projects. 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 coordinate 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 & Responsibilities:
|Execute device design development activities such as design of prototypes and final product, engineering testing, design verification testing, review and approval of experimental protocols and reports, product and process root cause analysis and problem solving, design verification, design validation and design transfer.|
|Review and approve design input and output documentation such as , product requirements, usability file, component and assembly drawings utilizing SolidWorks, bill of materials generation, tolerance analyses, FEA and Flow Simulation reports|
|Participate in product commercialization activities such as design for assembly, part and cost reduction including interfacing with the device manufacturer, component suppliers, and assembly equipment vendors as needed.|
|Participate in the Risk Management process and review and approve file documents including User FMEA, Design FMEA, Process FMEA and material selection rational for biocompatibility.|
|Review and approve Design Verification protocols and technical reports. Must have a working knowledge of statistics including determination of sample size, design of experiments and ANOVA.|
|Review and approve transfer of design to manufacture of product. Review and approve manufacturing documentation such as assembly work instruction, validation protocols and reports, batch records, and IQ OQ PQ equipment qualifications.|
|Support IP, Commercial, Regulatory, Quality, Procurement, Operations and Project management with clear and concise communication, documents and other information as needed for the project success.|
- 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
Bachelor of Science in Mechanical or Biomedical Engineering
- 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
Company / Industry Related Knowledge:
Extensive working 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.