Job Summary
We're seeking a Quality Engineer with an electrical background to investigate product complaints and monitor performance for medical device therapy products. In this hybrid role, you'll review returned product analysis and post-market surveillance data to identify patterns and trends, perform complaint investigations, and collaborate with cross-functional teams to mitigate risk and improve patient safety. This is a great opportunity for an EE or Biomedical Engineering graduate looking to apply technical circuit analysis skills within a quality and regulatory-focused environment.
Responsibilities
- Review returned product lab analysis, customer feedback, and historical data to identify proper coding for product complaints
- Perform complaint investigations in accordance with local and global processes
- Analyze post-market surveillance data for patterns and trends, investigating as necessary
- Respond to Competent Authority Requests
- Communicate product performance through formal presentations to management committees and design teams
- Provide input for process improvement and help develop tactical approaches to implement team strategies
- Perform data analysis for Product Performance and Risk Management documentation using statistical methods and software
Requirements
- Bachelor's degree or higher in Electrical or Biomedical Engineering
- Electrical background required, with experience investigating/reviewing electronic circuits and components
- 1-3 years of relevant experience
- Understanding and command of highly technical engineering topics and applied statistics
- Ability to independently manage project work and consistently meet delivery dates
- Experience operating within quality system processes and procedures
- Strong verbal/written communication and data analysis skills
- Preferred: medical device experience, physical device analysis, Hazard Analysis and Risk Assessment, CAPA investigations, and understanding of post-market complaint tracking/trending regulations
- Hybrid schedule — onsite Tuesday, Wednesday, and Thursday in Arden Hills, MN
#GRPB
Equal Opportunity Employer/Veterans/Disabled. Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
Pay: $36.00 - $37.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
People with a criminal record are encouraged to apply
Work Location: In person
