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Sr. Manufacturing Engineer

Tandem Diabetes

Sr. Manufacturing Engineer

Tandem Diabetes

California - Barnes

·

On-site

·

Full-time

·

2w ago

Compensation

$108,600 - $135,750

Benefits & Perks

Healthcare

401(k)

Flexible Hours

Healthcare

401k

Flexible Hours

Required Skills

Manufacturing engineering

FDA/GMP/ISO compliance

Process improvement

Problem-solving

Technical documentation

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:

Provides technical leadership to the Manufacturing Engineering team under the guidance of the Manufacturing Engineering Manager. Performs all aspects of manufacturing engineering for Cartridge.  Leads Manufacturing Engineering activities for both new development efforts, including all aspects of new product introduction, and sustaining.  Responsible for projects that effect Safety, Quality, Delivery, Innovation and Cost.

Sr. Manufacturing Engineers at Tandem are also responsible for:

  • Supports the technical development of automated and manual assembly techniques, tooling, and identifies electro/mechanical testing development to improve product manufacturability.

  • Supports operations with the creation/routing of BOMs, DHRs, Part Numbers, work instructions, and metrics:

  • Develops and updates work instructions and bill of materials.

  • Manages and releases change orders.

  • Supports Manufacturing Engineering Management in applicable Metrics, such as cost, schedule adherence, yield, etc.

  • Defines continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to optimize process efficiency, reduce costs and lead-times.

  • Leads supplier development and qualification activities.

  • Defines requirements for supplier manufacturing and test processes and assists in reviewing Supplier Capability.

  • Provides training to manufacturing personnel on procedure, process, and equipment changes.

  • Working with the Quality and R&D groups, leads root cause failure investigations, and develops and implements corrective and preventive action, as required.

  • Tools include PFMECA, FMECA, DOE, Fault Tree analysis.

  • Supports R&D and Design Engineering to aid in the transition of new products and processes to manufacturing:

  • Leads the development of production test plans, requirements, and specifications.

  • Leads Operations, Manufacturing and Production leaders in Prototype Development Planning activities and pilot build activities.

  • 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.

WHEN & WHERE YOU’LL WORK: Onsite: This position will work fully onsite at our manufacturing facility in San Diego, California. Equipment for the role will be provided, and training will occur onsite.

Schedule: This position will work Monday

  • Friday from 8:00 AM - 5:00 PM PST or equivalent based on time zone.

WHAT YOU’LL NEED: Knowledge, skills & abilities:

  • Awareness of federal and other regulations, e.g. QSRs, ISO 14971 IEC 60601 series.
  • Knowledge of Good Documentation Practices (GDP).
  • Good analytical and organizational skills with the ability to prioritize workload.
  • Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
  • Skilled at creating a cooperative team environment.
  • Ability to objectively evaluate situations and make recommendations for changes in light of overall project demands.
  • Experienced with MS Office, knowledge of Solidworks software desirable.

Minimum certifications/educational level:

  • B.S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.

Minimum experience:

  • 4 years of experience in medical device manufacturing.
  • Experience in an FDA/GMP/ISO environment.

Preferred Experience:

  • Lean Manufacturing and 6 sigma experience.
  • Experience in process design, development, test, and validation.

COMPENSATION & BENEFITS:

The starting base pay range for this position is $108,600 to $135,750 annually. 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 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.

Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

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About Tandem Diabetes

Tandem Diabetes

Tandem Diabetes Care, Inc. is an American medical device manufacturer based in San Diego, California. The company develops medical technologies for the treatment of diabetes and specifically insulin infusion therapy.

501-1,000

Employees

San Diego

Headquarters

Reviews

3.6

3 reviews

Work Life Balance

3.0

Compensation

3.0

Culture

4.0

Career

3.0

Management

3.5

67%

Recommend to a Friend

Pros

Excellent customer service and support

Quick response times from staff

Honest and straightforward communication

Cons

Software compatibility issues

Short notice for required updates

Limited software availability in US

Salary Ranges

197 data points

Senior/L5

Senior/L5 · SR. REPORTING ANALYST

1 reports

$115,000

total / year

Base

$100,000

Stock

-

Bonus

-

$115,000

$115,000

Interview Experience

39 interviews

Difficulty

3.1

/ 5

Duration

14-28 weeks

Offer Rate

33%

Experience

Positive 64%

Neutral 17%

Negative 19%

Interview Process

1

Phone Screen

2

Technical Interview

3

Hiring Manager

4

Team Fit

Common Questions

Technical skills

Past experience

Team collaboration

Problem solving