Mechanical Engineer II (20170814)

Tandem Diabetes Care San Diego , CA 92140

Posted 2 months ago

What you'll be doing:

A team member responsible for designing and analyzing mechanical systems and disposables for the Company's medical devices.

Who we are:

Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. "In Tandem" means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.

We've have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.

Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild

What you need for this position:

PRIMARY DUTIES & RESPONSIBILITIES:

  • Responsible for the research and development of mechanical components for the Company's medical devices, utilizing knowledge of mechanical theory and materials properties.

  • Works independently within design controls and contributes to the design history file for medical devices by reviewing product requirements and specifications, documenting the design process, participating in formal design reviews and verifying the product performance with formal test methods, protocols and reports.

  • Plans, designs, develops, modifies and evaluates mechanical parts, components, integrated mechanical systems, equipment, packaging, and optical systems.

  • Responsible for the design and verification of component fabrication, prototype mechanical systems, experimental designs and specialized test equipment.

  • Analyzes equipment and processes to establish operating parameters by conducting experiments, evaluating results and performing process capability analysis (Cpk).

  • Develops test methods and verifies performance with Gage R&R studies.

  • Develops test methodology to support product manufacturing.

  • Responsible for sustaining engineering and supporting design changes of existing products.

  • Recommends selection of components and equipment based on analysis of requirements as well as component specifications and reliability.

  • Participates in evaluating the reliability of materials, properties and techniques used in production.

  • Troubleshoots product design and assembly tooling and processes.

  • Writes technical documentation for technicians and operators in order for the equipment to be operated safely and effectively.

  • Participates in product and process risk assessments and mitigations.

  • May assist in developing and delivering training for other engineers, technicians and operators.

  • Confirms completion of required training plan before assuming job responsibilities.

  • Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

  • Other responsibilities as assigned.

REQUIRED QUALIFICATIONS:

Knowledge, skills & abilities:

  • Demonstrated proficiency in designing mechanical parts and assemblies and creating appropriate design documentation.

  • Demonstrated proficiency in writing test methods, protocols and reports.

  • Has a strong understanding of tying product requirements to the design.

  • Ability to integrate information from many sources across the business in order to make decisions for product development.

  • Ability to communicate technical knowledge to varying levels within organization.

  • Some knowledge of Good Documentation Practices (GDP).

  • Proficient with SolidWorks software and analysis tools.

  • Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

  • Excellent written communication skills.

  • Capable of using statistical techniques and tools to summarize data and support conclusions.

  • Able to work effectively in a team environment at all levels within the organization.

  • Able to alter behavior and opinions in light of new information.

  • Experience with MS Office.

Minimum certifications/educational level:

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering or related field

or equivalent combination of education and applicable job experience.

Minimum experience:

  • 2 years of experience in the medical device field including detailed design, design testing, test documentation, and prototype fabrication of biomedical devices.

SCOPE:

  • Understands professional concepts of area of specialization and uses them to creatively resolve issues.

  • Works on problems of varied scope where analysis of situations or data requires a review of a variety of factors.

  • Normally receives general instructions on routine work, requires instructions only on new projects or assignments.

  • Customarily and regularly exercises discretion and independent judgment.

What's in it for you?

We've got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care Tandem's got you covered!

Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.

Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.

Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.

Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick's Day, costume-contest for Halloween, and the annual JDRF walk.


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Mechanical Engineer II (20170814)

Tandem Diabetes Care