Endologix, Inc

Staff Design Assurance Engineer, NPD

Job ID
2017-1767
US-CA-Santa Rosa

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.

 

Facilitate compliance to applicable internal and external requirements during the product development cycle and commercialization of new products. Collaborate with the R&D, Regulatory, Clinical, Marketing and other departments to help facilitate the successful execution of the New Product Development process and launching of robust products. Responsible and accountable for Design Assurance Engineering deliverables required within the product development program.

Responsibilities

  • Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and
  • Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical
  • Lead test method development and validation activities for New Product Development programs.
  • Initiate new supplier relationships and drive opportunities with existing suppliers including support for IQ/OQ/PQ development to ensure robust product design.
  • Lead Design Assurance Engineering activities to improve customer satisfaction and successful achievement of corporate and department quality
  • Support failure investigations for product failures encountered during the Design and Development lifecycle of new
  • Ensure Design Assurance Engineering support of customer complaint investigations as required.
  • Maintain an up-to-date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques including company products, policies, and procedures.
  • Lead the development of Risk Management documentation and facilitates updates to Risk Management files through regularly scheduled meetings.
  • Identifies hazards, mitigates risks associated with hazards and updates occurrence ratings in Use and Design FMEA
  • Perform other duties as assigned by supervisor.

     

 

Qualifications

Minimum Education:

  • Bachelor’s degree in engineering or science discipline 8+ years of experience
  • Master’s degree in engineering or science discipline 5+ years of experience
  • PhD in engineering or science discipline 3+ years of experience

Minimum Experience:

  •  Minimum of 8 years of experience with a Bachelor’s degree; or 5 years and a Master’s degree; or a PhD with 3 years of experience; or equivalent combination of education and experience in medical devices preferably implantable medical devices
  • Excellent verbal and written communication skills required.
  • Working knowledge of GMP/QSR, ISO, Medical Device Directive, and other applicable regulations is expected.
  • Working knowledge of desktop computer, office software, and e-mail is required.  Knowledge of Minitab statistical software is preferred.
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines.
  • Detail oriented.  Must be accurate in performing statistical techniques and review of documentation containing highly detailed information/data

Desired/Preferred Qualifications

Minitab statistical software

CQE Certification

 

Specific Skills, Knowledge & Behaviors

 

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

 

Core 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:  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.

 

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

 

 

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