Previous Job
Product Analysis Engineer
Ref No.: 18-04420
Location: Burlington, Massachusetts
Position Type:Contract
Start Date: 05/07/2018
Title: Product Analysis Engineer
Location: Burlington, MA
Type: 1+ year contract, with potential for conversion to direct hire or extension

We are seeking an experienced, high caliber Product Analysis Engineer I to analyze and identify root causes and initiate corrective action regarding customer complaints.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on St. Jude Medical:
  • Perform analysis of post-market products 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
  • 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
Your experience(s), education and knowledge will further expand St. Jude Medical's marketplace success:
  • 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