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Product Development Engineer

Quest Staffing Services, Inc.

Product Development Engineer

Oxnard, CA
Full Time
Paid
  • Responsibilities

    Job Description

    SUMMARY/PURPOSE:

    Under general guidance, the Product Development Engineer will identity the raw materials, equipment, processes and facility improvements necessary to facilitate the fabrication and packaging of a wide variety of medical devices. The Product Development Engineer will be responsible for the development and execution of protocols and written reports in the support of material, equipment and process qualification/validation activities, and will perform process troubleshooting as well as product and process improvement activities on both new and existing manufacturing systems.

     

    ESSENTIAL FUNCTIONS:

    • Evaluate product concepts for design feasibility, preliminary manufacturability and potential environmental health and safety issues created through device manufacturing.
    • Ability to clearly understand project design inputs and expected project output.
    • Ability to accurately determine time and materials required for a given project, accurately convey this information to management and work within the given project confines.
    • Develop specifications for raw materials, components, sub-assemblies, incoming Quality Control and product performance which will comply with customer and regulatory requirements.
    • Evaluate manufacturing concepts and create preliminary manufacturability assessments which incorporate the use of the selected materials, equipment, tooling and processes.
    • Search, evaluate and select outside vendors/suppliers for materials, and related processing equipment.
    • Identify device, packaging and equipment performance testing requirements and methodology.
    • Develop and execute test protocols in support of related product/process qualification/validation activity.
    • Perform preliminary testing and evaluations of product and packaging through in-house and contract laboratory testing.
    • Develop raw material, sub-assembly finished device and manufacturing documentation.
    • Troubleshoot both new and existing manufacturing and packaging processes, proposing and implementing corrective action.
    • Perform periotic equipment requalification and process revalidation activities.
    • Capable of operating and maintaining Laser Scanning, Laser Engraving, 3D Printing, presses, mixers, scales as well as other basic laboratory and office equipment.
    • Capable of operating basic shop equipment such as drill press, saws, power tools and hand tools.
    • Must possess sufficient communication and writing skills to assure that adequate detail is correctly conveyed and appropriately presented.
    • Ability to coordinate and complete projects within the given deadlines and budgetary constraints.
    • Ability to produce output which meets Engineering, Regulatory Affairs, QA, Production, Marketing and customer/end user expectations.
    • Capable of maintaining effective and regular interactions with fellow department members and outside contractors/vendors.
    • Ability to coordinate and synchronize multiple projects.

    MARGINAL FUNCTIONS:

    • Participate in other work functions as directed.

    PHYSICAL DEMANDS:

    The physical demands and work environment characteristics 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.

    WHILE PERFORMING THE DUTIES OF THIS JOB:

    • The employee is frequently required to sit at a computer workstation for extended periods of time while typing and using a mouse or other curser controlling device.
    • The employee is regularly required to stand, walk and use hands to finger, handle or feel.
    • The employee is frequently required to reach with hands or arms, and talk and hear.
    • The employee frequently will use either one or both hands to firmly grasp, push and/or pull.
    • T he employee will occasionally reach overhead to grasp objects and lift or carry up to 60 pounds.
    • It will be necessary to be around equipment and machinery and work in a laboratory, machine shop, maintenance shop and cleanroom environment.
    • Normal 20/20 vision ability (with corrective lenses, if needed) is required.

    QUALIFICATIONS AND REQUIREMENTS:

    To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skills and/or abilities required.

    EDUCATION:

    Bachelor’s Degree and two to four years related experience or equivalent combination of education and experience.

    SKILLS:

    • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
    • Ability to write reports, business correspondence, and procedure manuals in English.
    •  Ability to effectively present information and respond to question from groups of managers, clients, customers, the general public and board of directors.
    • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
    • Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
    • Manual dexterity required.
    • Ability to safely use basic hand tools as well as relevant laboratory and maintenance equipment such as drills, saws, sanders, presses, ovens scales mixers and calipers.
    • Ability to clearly present information in written form including equipment qualifications, test protocols, technical reports, emails and informal memoranda.
    • Ability to function in a controlled environment regulated by FDA GMPs and ISO guidelines.
    • Ability to maintain accuracy, consistency and quality in a fast-paced, multi-task environment and be flexible in changing daily workload priorities as directed.
    • Ability to accurately perform detail-oriented work within a laboratory, machine shop, maintenance shop and cleanroom environment.
    • Must possess good computer skills and be proficient with MS Word, Excel, Office and SolidWorks programs. In addition, must be able to work with data processing, programming, systems design, and problem analysis.
    • Ability to work with Take initiative and make decisions, for projects.

    MATHEMATICAL SKILLS:

    • Ability to apply mathematical concepts such as fundamentals of plane and solid geometry, and trigonometry.

    EXPERIENCE:

    • Prior experience in the Medical Device and/or Pharmaceutical related industry desired Five years’ work experience as a Technician in an Engineering environment.
    • Five years’ work experience in silicone processing and/or silicone device manufacturing.
    • Experience working with FDA GMP’s.

    TRAINING:

    • Training requirements for this position are called out in the Required Employee Training Matrix..

    TO BE CONSIDERED FOR THIS ROLE, PLEASE SUBMIT YOUR UPDATED RESUME TO GERRY@QUEST-STAFFING.COM ALONG WITH YOUR PAY EXPECTATIONS.  CALL OUR OFFICE FOR MORE DETAILS AT (805) 983-3959.