Failure Investigation Technician II

Tandem Diabetes Care Inc.; California (MO); Sur place; USD 31 000 - 37 000; Plein temps

Avantages offerts par ce poste

Health benefits

HSA/FSA

Paid holidays

Paid time off

401k with match

Employee Stock Purchase Plan

Résumé du poste

Tandem Diabetes Care is seeking a Failure Investigation Technician II to evaluate returned medical devices in an FDA-regulated environment. You will perform electrical and mechanical failure analysis, review manufacturing data, and prepare reports supporting CAPA and the complaint process.

The role requires 3 years in a multidisciplinary manufacturing engineering setting, experience with electrical schematics, and familiarity with GMP/QSR.

Qualifications

• High school diploma or equivalent required; associate degree in electronics or computer technology preferred.
• 3 years experience in a multidisciplinary manufacturing engineering support environment in instrumentation, biomedical, or consumer electronics.
• Experience in high-volume medical device assembly of plastic components is desirable and FDA/GMP/ISO experience preferred.

Responsabilités

• Participates in complaint investigations and failure analysis of returned insulin pumps and disposable devices.
• Conduits verification testing of returned medical devices to approved protocols.
• Evaluates product manufacturing history and test results to identify root causes and CAPA needs.
• Documents findings and contributes to CAPA reports and quality assurance processes.

Connaissances

QSR/GMP knowledge

Electronic devices knowledge

Hand tools operation

Schematic interpretation

Verbal/written communication

Team collaboration

Multitasking

PPE knowledge

MS Office proficiency

Solidworks (Desirable)

Formation

High School Diploma or equivalent

Associate’s Degree in Electronics or Computer Technology

Outils

Soldering irons

Micrometers

Calipers

Drills

Solidworks

Description du poste

GROW WITH US: 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. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE

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. Failure Investigation Technician II's are also responsible for: 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. Performs other assignments as assigned.

WHAT YOU'LL NEED

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.

COMPENSATION & BENEFITS

• The base hourly pay for this position is $22.50 - $27.00.
• 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 incentive compensation, equity, and a robust benefits package Tandem offers health care benefits such as medical, dental, vision available 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 you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.
• Learn more about Tandem’s benefits here!

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.

WHY YOU'LL LOVE WORKING HERE

At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don't meet 100% of a job description’s criteria – maybe you're feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. 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.

REFERRALS

We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company's pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California.