Failure Investigation Technician II
Tandem Diabetes Care
Summary
Evaluates returned product in an FDA regulated environment. Performs electrical and mechanical failure analysis techniques in support of failure investigation. Provides review of product manufacturing data including production test results to evaluate lot to lot correlation of failures. Prepares failure investigation reports in support of Tandem's Complaint Process. Participates in process improvement activities as requested to improve the failure analysis process and/or reduce failures.
Job description
Responsibilities
- Participates in complaint investigations and failure analysis of returned insulin pumps and disposable devices
- Conducts verification testing of returned medical devices to approved protocols
- Evaluates product manufacturing history, including test results, in support of identifying lot to lot correlations for root cause
- Tests and measures component level failure analysis to determine performance and failure modes
- Interprets electrical schematics in support of troubleshooting electromechanical devices
- Documents findings and provides failure analysis information for CAPA reports
- Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development
- Works with Engineering and Quality staff as needed to investigate failures and determine root cause
- Performs technical tasks per written and verbal instructions in compliance with company and cGMP requirements including accurate documentation
Knowledge, Skills & Abilities
- Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs)
- Strong knowledge of electronic devices, systems and components
- Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
- Ability to operate electrical and mechanical equipment and interpret results
- Must be able to read and interpret mechanical drawings and electrical schematics
- Able to effectively share information related to work product in verbal and written form
- Able to contribute to the team by supporting the acceptance of new team members
- Demonstrated ability to work accurately, to follow instructions and schedules, and handle multiple priorities
- Has knowledge of personal protective equipment (PPE) for protecting against blood-borne and other bio-hazardous pathogens
- Competent with Microsoft Office and the Internet
- Solidworks experience desirable
Minimum Education
High School Diploma or equivalent required. Associate's Degree in Electronics or Computer Technology or equivalent combination of education and applicable job experience.
Minimum Experience
3 years experience in a multidisciplinary manufacturing engineering support environment in one of the following industries: Instrumentation, Biomedical, or Consumer Electronics to include Experience in high volume medical device assembly of plastic components desirable. Experience in FDA/GMP/ISO environment. Experience in Technical Service Operations. Experience with troubleshooting electromechanical assemblies.
Requirements
- High School Diploma or equivalent required
- Associate's Degree in Electronics or Computer Technology or equivalent combination of education and applicable job experience
- 3 years experience in a multidisciplinary manufacturing engineering support environment in one of the following industries: Instrumentation, Biomedical, or Consumer Electronics
- Experience in FDA/GMP/ISO environment
- Experience in Technical Service Operations
- Experience with troubleshooting electromechanical assemblies
- Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs)
- Strong knowledge of electronic devices, systems and components
- Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
- Ability to operate electrical and mechanical equipment and interpret results
- Must be able to read and interpret mechanical drawings and electrical schematics
- Able to effectively share information related to work product in verbal and written form
- Able to contribute to the team by supporting the acceptance of new team members
- Demonstrated ability to work accurately, to follow instructions and schedules, and handle multiple priorities
- Has knowledge of personal protective equipment (PPE) for protecting against blood-borne and other bio-hazardous pathogens
- Competent with Microsoft Office and the Internet
- Solidworks experience desirable
- Experience in high volume medical device assembly of plastic components desirable
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Flexible Spending Account
- 11 Paid Holidays
- 20 Days PTO
- 401(k) Matching
- Employee Stock Purchase Plan
- Incentive Compensation
- Equity
Company overview
Tandem Diabetes Care is a global medical device company specializing in advanced insulin delivery systems and diabetes management technologies. Founded in 2006 and headquartered in San Diego, California, the company has established itself as a leader in automated insulin delivery systems. Tandem's innovative product portfolio includes the Tandem Mobi system and t:slim X2 insulin pump, both featuring Control-IQ advanced hybrid closed-loop technology that significantly reduces the burden of diabetes management. The company's approach combines medical device expertise with consumer electronics design principles, creating user-friendly devices that have made Tandem the #1 recommended insulin pump brand among people living with diabetes for four consecutive years. With a workforce of 1,001-5,000 employees, Tandem operates globally, developing integrated solutions that connect insulin pumps with mobile applications and cloud-based platforms to provide comprehensive diabetes care. The company's mission focuses on creating new possibilities for patients, their loved ones, and healthcare providers through continuous innovation in diabetes technology.