Endologix, Inc

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Staff Manufacturing Engineer

Staff Manufacturing Engineer

Job ID 
2017-1727
Location 
US-CA-Irvine

More information about this job

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 

Engineer responsible for the design and development of manufacturing processes, tooling, and fixtures in support of a next generation AAA device. Collaborate with the R&D and Manufacturing organizations to help facilitate the successful execution of the New Product Development Process and launching of robust products.

Responsibilities

  • Design and develop manufacturing processes for new AAA products.

  • Design and develop fixtures and tooling for new AAA products/processes.

  • Leader of the development process with direct input into timelines and critical path items

  • Work with R&D and Manufacturing staff to ensure that design for manufacturability principles are applied to new processes.

  • Plan, schedule, and complete projects in a manner consistent with business objectives.

  • Operations liaison for the project team responsible for communications to all appropriate operations groups.

  • Develop and execute process validation protocols (IQ/OQ/PQ).

  • Analyze process data and make decisions/recommendations relating to process capability and DFM.

  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.

  • 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.

  • Contribute to the intellectual property position of the company via invention and patent applications.

  • Maintain current knowledge of medical, technical, and biomedical developments as related to company products.

  • Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance.

  • Support company goals and objectives, policies and procedures, and FDA regulations.

  • Ensure that all regulatory and internal policies are followed.

  • Assist engineering manager in development of engineers providing assistance with coaching and mentoring.

  • Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.

 

ADDITIONAL JOB DUTIES:

 

  • Perform other duties as assigned by supervisor.

Qualifications

  •  

Minimum Education:

 

       

  • Requires a Bachelor of Science degree in Engineering or related technical degree (i.e. physics or mathematics)

 

Minimum Experience:

 

 

  • Requires a minimum of 8 years related experience with a Bachelor’s degree; 6 years of related experience with a Masters degree, and 3 years with a PhD.
  • Experience with catheters and interventional delivery systems are preferred.
  • Knowledge in the following areas of manufacturing highly recommended, Balloon catheters, stent forming, PTFE, aseptic processing, pressure monitoring devices and injection mold design.

 

 

Specific Skills, Knowledge & Behaviors

 

  • (Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
  • Has the ability to use statistic techniques when analyzing data and make rational and logical decision based on 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)
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines

 

Core Competencies:

  1. Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
  2. Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
  3. Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
  4. Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
  5. Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
  6. Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
  7. Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
  8. Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
  9. Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

Equipment Use & Abilities Required:

 

 

Equipment Use:   Copy machines, fax machines, 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 reports, 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.

 

EEO:

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

                                            

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800