Failure Investigation Technician I

Tandem Diabetes Care; San Diego (CA); On-site; USD 28,240 - 34,440; Full time

Job summary

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. This entry-level position provides technical and process assistance to Sr.

Technicians for the evaluation of returned products within an FDA regulated environment. Failure Investigation Technicians apply technical knowledge on electrical and mechanical characteristics to determine causes of failure, perform verification

Qualifications

• 2-year college courses in Science or Engineering or an equivalent combination of education and applicable job experience.
• 1 year’s experience in a technical role preferably in a medical device manufacturing environment.
• Experience in product development, test, and validation.
• Ability to lift or move up to 45 pounds.
• Basic knowledge of electrical and mechanical theories.
• Ability to express technically complicated ideas and explain them to others.
• Skill at effectively sharing 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 the 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.

Responsibilities

• Performs 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 release 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 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 for 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.

Skills

Technical communication

Team collaboration

Problem solving

Education

2-year college courses in Science/Engineering

Tools

Electrical test equipment

PPE knowledge

Microsoft Office

Internet proficiency

Job description

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to innovate every day, put people first, and take the no-shortcuts approach that has propelled us to become a leader in the diabetes technology industry.

A Day In The Life

This entry‑level position provides technical and process assistance to Sr. Technicians for the evaluation of returned products within an FDA regulated environment. Failure Investigation Technicians provide 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. They also follow methods, processes, procedures and equipment operating procedures to assist the failure investigation process.

• Performs 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 release 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 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 for 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.

When & Where You’ll Work

This role is on‑site five days a week at our Barnes Canyon office in San Diego due to the nature of the work involved.

What You’ll Need

• 2‑years of college courses in Science or Engineering or a related field, or an equivalent combination of education and applicable job experience.
• 1 year’s experience in a technical role preferably in a medical device manufacturing environment.
• Experience in product development, test, and validation.
• Ability to lift or move up to 45 pounds.
• Basic knowledge of electrical and mechanical theories.
• Ability to express technically complicated ideas and explain them to others.
• Skill at effectively sharing 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 the 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.

The starting base pay range for this position is $20.50 - $25.00 per hour. Base pay will vary based on job‑related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.

Tandem offers health care benefits such as medical, dental, vision available from your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and access to a 401(k) plan with company match as well as an Employee Stock Purchase plan.

You Should Know

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre‑employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

Sponsorship

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Tandem is firmly committed to being an equal‑opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.