Failure Investigation Technician I
About The Position
This is an entry-level position that provides technical and process assistance to Sr. Technicians for the evaluation of returned product within an FDA regulated environment. The role 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. The Failure Investigation Technician follows methods, processes, procedures and equipment operating procedures to assist the failure investigation process.
Requirements
- 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.
- 1 years’ experience in a technical role preferably in a medical device manufacturing environment.
- Experience in product development, test, and validation
Nice To Haves
- Associate Degree in Electronics Technology, Engineering Technology, Mechanical Technology, or a related technical discipline preferred.
- Equivalent combination of education, technical training, and relevant work experience will be considered.
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 rest results, in support of identifying lot to lot correlations for root cause.
- Investigates component level failure analysis to determine performance and failure modes.
- Interprets of 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.
- Other responsibilities as assigned.
Benefits
- medical
- dental
- vision
- health savings accounts
- flexible saving accounts
- 11 paid holidays per year
- a minimum of 20 days of paid time off (with accrual starting on day 1)
- access to a 401k plan with company match
- Employee Stock Purchase plan
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
