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Design/Process Engineer

FZIOMED INC

Design/Process Engineer

San Luis Obispo, CA
Full Time
Paid
  • Responsibilities

    Work in beautiful San Luis Obispo with a family oriented team.

    Design new products and make improvements to existing products. Designs, integrates, or improves current and new manufacturing systems or related processes

    Position essential duties and responsibilities: (other duties may be assigned)

    · Provide project management and design expertise to support product development/modifications/improvements.

    · Plan, formulate and execute engineering projects according to project requirements and timelines.

    · Provide support and technical input for quality assurance activities, including supplier development, approval and monitoring.

    · Ensure engineering activities are in compliance with the Design Control Procedure and QMS (Quality Management System)

    · Ensure efficient transfer of products to Production. Assist other departments as needed with product scale up, and process development.

    · Design new manufacturing processes.

    · Define and implement improvements to existing manufacturing processes to increase yields and reduce costs.

    · Develop specifications for new equipment and tooling including calibration and preventative maintenance requirements

    · Define equipment and process validation requirements and assist in developing and performing validation protocols.

    · Design and implement test control procedures, in conjunction with other team members. This includes test apparatus selection and/or design.

    · Perform root cause analysis to identify source(s) of failures and determine appropriate corrective actions.

    · Provide support and technical input for the operation and maintenance of compressed gas, DI (deionized) pure water, steam and electrical power systems.

    · Write procedures, specifications, protocols and technical reports.

    Job Complexity:

    Solve complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining optimal results.

    Essential experience and skills:

    · Bachelor's degree in Engineering (Mechanical, Chemical, Manufacturing, etc.) and 5+ years experience or equivalent combination of education and experience in a related environment.

    · Good written and verbal communication skills.

    · Experience and knowledge of lab equipment, test methods.

    · Must have knowledge of manufacturing and equipment validation methods.

    · Broad technical understanding of packaging, processing, quality systems, and manufacturing.

    · Strong problem solving and decision-making skills.

    · Computer proficient (Microsoft Word, Excel, Power Point, Solid Works).

    · Excellent project management skills.

    · Strong testing and development skills with a proven ability to reconcile project timing, business risks, and resources, to define a working plan of action and implement solutions.

    Reporting to this position: n/a

    Physical demands and work environment: The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    · Physical demands: While performing the duties of this job, the employee is regularly required to operate computer. Employee must occasionally lift and/or move up to 25 pounds.

    Work environment: The noise level in the work environment is usually moderate