Failure Investigation Technician I
Tandem Diabetes Care
Summary
Entry-level position that provides technical and process assistance to Sr. Technicians for the evaluation of returned product within an FDA regulated environment. Provides technical knowledge on the electrical and mechanical characteristics of systems and/or integrated circuits, components, sub-components and systems to determine the cause of failure, including the verification of analog and digital performance.
Job description
Responsibilities
- Performs the failure investigations of returned insulin pumps and disposable devices; documents findings and provides data used for trending.
- Conducts verification testing of returned medical devices to approved protocols.
- Reviews product manufacturing history, including test results, in support of identifying lot to lot correlations for root cause.
- Investigates component level failure analysis to determine performance and failure modes.
- Interprets electrical schematics in support of troubleshooting of electromechanical devices.
- Reviews failure analysis reports, and recommends corrective actions to the Quality organization.
- Maintains investigation process and analyzes problem logs/trends to identify issues to Failure Investigation Management.
- Confirms completion of required training plan before assuming job responsibilities.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
Knowledge, Skills, and Experience
- Basic knowledge of the electrical and mechanical theories.
- Ability to express technically complicated ideas and explain them to others.
- Able to effectively share information regarding issues in written or verbal form.
- Skilled at participating in team cooperation and a commitment to team success.
- Proficient with Microsoft Office and Internet.
- Basic knowledge of electrical and mechanical test equipment.
- Familiar with personal protective equipment (PPE) for protecting against blood borne and other bio-hazardous pathogens.
Requirements
- High School Diploma or equivalent required.
- Associate Degree in Electronics Technology, Engineering Technology, Mechanical Technology, or a related technical discipline preferred.
- 1 year experience in a technical role preferably in a medical device manufacturing environment.
- Experience in product development, test, and validation.
- Basic knowledge of electrical and mechanical theories.
- Ability to express technically complicated ideas and explain them to others.
- Able to effectively share information regarding issues in written or verbal form.
- Skilled at participating in team cooperation and a commitment to team success.
- Proficient with Microsoft Office and Internet.
- Basic knowledge of electrical and mechanical test equipment.
- Familiar with personal protective equipment (PPE) for protecting against blood borne and other bio-hazardous pathogens.
Benefits
- Medical, Dental & Vision
- Health Savings Account
- Flexible Spending Account
- 11 Paid Holidays
- 20 Days PTO
- 401(k) Matching
- Employee Stock Purchase Plan
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.