Endologix, Inc

Returning Candidate?

Staff RGI Engineer

Staff RGI Engineer

Job ID 
2017-1686
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.

 

JOB SCOPE AND PURPOSE:

Manages and conducts evaluation of returned product associated with product complaints.  Responsible for leading complaint related investigations into new or elevated failures or observations observed during complaint analysis or trending. Collaborates with R&D, Regulatory, Clinical, Medical Affairs, Sales and other departments to help facilitate the successful execution of the product analysis as part of the complaint investigation processes. Responsible and accountable for Returned Goods Investigation deliverables.

 

Responsibilities

MAJOR DUTIES:

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Provide leadership to the Returned Goods Investigation team
  • Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
  • Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
  • Collaborate with New Product Development (NPD) to provide design inputs from Returned Goods Investigation, including inputs into risk management, product design and effectiveness.
  • Lead failure investigations for alleged product failures associated with customer complaints.
  • Ensure Quality Engineering support of customer complaint investigations as required.
  • Maintain an up‑to‑date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Field Assurance and Statistical Techniques.
  • Maintain an up‑to‑date knowledge of the company products, policies, and procedures.
  • Leads the development of Returned Goods Investigation process and documentation.
  • Lead the updates of Risk Benefit Analysis documentation for commercial products which have completed the New Product Development (NPD) lifecycle.
  • Connects with Design Assurance Engineering (DAE) to help identify hazards, mitigate risks associated with hazards and ensure the update of occurrence ratings in Use and Design .FMEA files.
  • As needed, participate in the training and development of other employees.
  • Returned Goods Investigation

 

ADDITIONAL JOB DUTIES:

  • Perform other duties as assigned by supervisor. 

Qualifications

QUALIFICATIONS

·         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.

·         Must be accurate in handling detailed information/data. Must be accurate in performing statistical techniques and review of documentation containing highly detailed information/data.

 

Minimum Education:

 

·         Bachelor's degree in Engineering from a four-year college or university or related major required; Masters of Science (MS) degree in Engineering or Master’s degree preferred

 

Minimum Experience:

 

·         Eight years of medical device experience with a Bachelor’s degree, or four years with a Master’s degree or above.  Experience in Class III medical devices preferred.  Experience with vascular devices highly preferred.

 

Specific Skills, Knowledge & Behaviors

 

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

 

Supervisor 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: Challenge and motivate people to reach their highest potential; Create an environment that encourages risk-taking; Set clear performance standards and hold people accountable for results; Value, recognize and reward the achievement of others; Promote teamwork; Encourage others to pursue challenging goals and to challenge the status quo; Foster continuous professional development and career growth of a diverse workforce; Provide challenging work assignments and development opportunities; Identify and champion high potential talent as a company resource; Coach and mentor future leaders; Require people to expand their capabilities, knowledge and skills; Function as both team player and leader; Provide frequent, informal feedback; Recognize the contributions of others; Continuously strive to increase and refine supervisory skills; 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