Job Title —Engineer II Product Development

Company —Vastek Inc.

Location —San Diego, California.

Job Description:

  • • Provide technical assistance required to plan and implement specified projects to be completed including organizing and leading members of various departments, planning, scheduling and coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc. in a manner consistent with company objectives.
  • • Utilize engineering skills & apply knowledge of mechanical engineering/design principles of centrifugal pumps, peristaltic roller pumps, mechanisms, shafts, fasteners and structures to solve engineering problems at the component through system level.
  • • Create and edit 3D CAD models and drawing files using SolidWorks and Siemens NX.
  • • Develop 3D CAD designs to improve the current Pump Control Unit device.
  • • Benchmark resistive touchscreen devices to document industry best practices and best designs to integrate the design concepts in new pump control unit touchscreen device.
  • • Use rapid prototyping, 3D Printing to create proof-of-concept models.
  • • Identify issues with assembly of roller pumps and centrifugal pumps and work with senior engineers and outside CAD experts to get them resolved in future designs.
  • • Write test protocols and conduct tests to verify and validate functionality of new generation roller pumps, centrifugal pumps, pump control unit as part of design output.
  • • Work with outside suppliers to solve assembly and manufacturing issues faced during design of pump control unit.
  • • Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • • Apply engineering knowledge to the design and development of new products as well as product changes and enhancements.
  • • Work with cross functional team members to develop new products and coordinate introduction of new products and improvements of existing products/processes.
  • • Contribute to the intellectual property position of the Company via invention and patent applications.
  • • Develop and maintain knowledge in the medical device industry, including understanding of current technologies and trends, through actions such as professional memberships, attendance at conferences and/or seminars, subscription to trade magazines, etc.
  • • Gather, track and analyze data for meetings etc., as required.
  • • Maintain accurate documentation of concepts, designs, drawings and lab notebooks.
  • • Develop a knowledge and understanding of medical devices, customers, and customer needs.
  • • Perform other duties as assigned.
  • Vastek Inc requires its applicants to have at least a bachelors degree or higher in an engineering discipline such as industrial engineering, mechanical engineering, manufacturing engineering, or a closely related field.

    Send resume and refer to job title to attn.: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101.

    Job Title —Validation Engineer (Job Code 001)

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek, Inc. has openings in San Diego, CA) Validation Engineer (Job Code 001): Provide technical expertise to define approaches and execution of system validation activities in accordance with applicable regulations, procedures, and industry guidance. Develop Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, quality standard policies and standard operating procedures, test protocols (Installation Qualification/Operational Qualification/Performance Qualification), and Summary Reports of critical manufacturing equipment, facilities, and utility systems. Execution of Test Protocols, including: identification and resolution of non-conformance/deviations. Develop change control activities for equipment and create various manufacturing processes and ensure proper justification of statistical analysis and hypothesis testing. Generate risk management deliverables such as System Impact Assessments, Criticality Assessments, Preliminary Hazard Analysis Assessments, and Risk Management Reports. Will work in unanticipated locations.

    Requires Masters in Industrial Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Engineering Management or closely related field.

    Send resume and refer to job title/code to attn: Daniella Loza, VAStek, Inc. 1230 Columbia Street, Suite 1180, San Diego, CA 92101 (refer to job title).

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