Endologix, Inc

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Sr. Manufacturing Engineer

Sr. Manufacturing Engineer

Job ID 
2017-1727
Location 
US-CA-Irvine

More information about this job

Overview

Perform necessary Engineering activities to support daily production requirements and schedules in order to enhance productivity and product quality.

Responsibilities

  • Provide engineering support to production department in troubleshooting and resolving technical problems.
  • Support manufacturing and quality with addressing non-conformances, using Root Cause Analysis methods
  • Design, develop, or improve manufacturing processes for new products and/or changes to existing products
  • Design, develop or improve fixtures and tooling for manufacturing process
  • Write &/or execute equipment qualifications protocols and reports (IQ/ OQ/ PQ)
  • Write &/or execute process validation protocols and reports (OQ/ PQ/ PPQ)
  • Maintain accurate documentation of concepts, designs, and processes.
  • Analyze process data and make decisions/recommendations relating to process capability and DFM
  • Investigate benefits and features of capital equipment and generate capital appropriation justifications
  • Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
  • Contact and address component and/or raw material issues with suppliers
  • Plan, schedule, and complete projects in a manner consistent with business objectives
  • Contribute to the intellectual property position of the company via invention and patent applications
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
  • Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
  • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
  • Ensure that all regulatory and internal policies are followed
  • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.

 

ADDITIONAL JOB DUTIES:

 

  • Perform other duties as assigned by supervisor.
  • Assist engineering manager in development of engineers providing assistance with coaching and mentoring
  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.

Qualifications

    • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
    • Has the ability to use moderate to advanced statistic techniques when analyzing data and make rational and logical decision base the that analysis
    • Applicable knowledge of Minitab, JMP, or other statistic tools
    • Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill)
    • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.  
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.                                                                                                                                                                                                         

     

    Minimum Education:

     

    ·         Requires a Bachelor’s degree in Engineering or relative discipline.

     

    Minimum Experience:

     

    ·         Requires a minimum of 5 years in medical device, biotechnology, bioengineering, or equivalent. Alternately, three (3) years and a Master’s degree or equivalent combination of education and experience may be accepted.

     

    Specific Skills, Knowledge & Behaviors

     

    (To perform the job successfully, an individual should demonstrate the following competencies):

     

    • Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.
    • Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
    • Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
    • Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.
    • Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.
    • Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.
    • Written Communication: Write clearly and informatively; Create documents that are complete and accurate.
    • Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.
    • Decisions: Make timely and sound decisions; Take risks and manage them intelligently.
    • Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
    • Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

     

    Equipment Use & Abilities Required:

     

    • Equipment Use: Calculators and personal computers and computer terminals.
    • Computer Skills: Software proficiency in Microsoft Office Suite.
    • Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.   Ability to write report business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
    • Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
    • Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

     

     

     

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

     

    The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.