Product Analysis Engineer in Burlington, MA at Volt

Date Posted: 3/9/2018

Job Snapshot

Job Description

Position: Product Analysis Engineer I

Location: Burlington, MA

Status: 5-month contract

We are seeking an experienced, high caliber Product Analysis Engineer I to analyze and identify root causes and initiate corrective action regarding customer complaints.


  • Perform analysis of customer returned product including but not limited to: HeartMate LVADs, HeartMate batteries, HeartMate System Controllers, Printed Circuit Boards (PCBs), HeartMate Battery Clips, HeartMate Perc Lead/electrical wires, Heartmate Surgical Tools, PHP, and all other electronic and non-electronic related component analysis
  • Work closely with Regulatory Affairs, Technical Service, Sales/Marketing, Manufacturing, R&D and Quality Control to assure prompt attention and resolution to customer complaints
  • Analyze components forwarded from Technical Service found to be suspect during Technical Services analysis/repair of components/equipment
  • Coordinates and reviews outside analysis of components and parts, where applicable
  • Completes required paperwork to document analysis, results and corrective/preventive action in relation to investigation
  • Enters data into and updates applicable computer databases as needed/required
  • Generates reports on analysis and generates complaint data as required/requested
  • Assists RPA technicians with analysis of LVAS as required
  • Recommends product improvement designs, inspection and manufacturing processes based upon evaluation of failure investigations
  • Participates on Complaint, Corrective Action and Project teams
  • Assures timely processing, segregation and disposition of field returns associated with customer complaints
  • Trends complaint activity
  • Develops and maintains a complaint status tracking system and provides management reports
  • Supports and works with other departments and vendors, as required
  • Cross trains within Complaint/Returned Product Analysis process to enable individual to be utilized in any job function/job within the Complaint/RPA process
  • Maintains an awareness of the cost of quality and strive to reduce while implementing activities to improve product safety and reliability
  • Keeps abreast of FDA, GMP’s ISO 9000, CSA, UL and other applicable regulations, standards and technology development in Quality Assurance throughout the industry
  • Promotes and assures full adherence to corporate, QA/QC policies and protocols
  • Performs other duties and projects, as assigned


  • Bachelor’s degree in Biomedical, Electrical or Mechanical Engineering with up to a year of related industry experience; or an equivalent combination of education and experience

Your preferred qualifications and education:

  • Experience in a Class II or Class III medical device company preferred

Please apply to position or contact Sondeep "Sunny" Singh at (317) 685-2200 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer