Manufacturing Engineer II
Tandem Diabetes Care
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 a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.
Tandem Diabetes Care is proud to manufacture and sell the t:slim X2 insulin pump with Control-IQ technology. We’re also 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. Since many of our own team members live with type 1 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:
This individual applies science and engineering disciplines, methods, and knowledge to the manufacture of infusion sets and related technologies. Key areas of focus include line support; cost reduction initiatives; process development, improvement, optimization, and qualification to assure conformance to established standards and specifications.
- Assessment and qualification of new suppliers and/or new Production/test equipment.
- Partner closely with both internal (Operations, Quality, Supply Chain, PD, Marketing teams) and external (CM’s, Contractors, Equipment Suppliers) resources.
- Develop accurate, detailed, and linked project schedules and other project tracking tools by partnering with internal and external stakeholders.
- Creates, manages, and releases change orders.
- Identifying opportunities and techniques to streamline existing processes.
- Troubleshooting Production equipment, programs, and processes.
- Collaboration with Quality and/or R&D engineer(s) to resolve Quality issues.
- Tooling and Fixturing design, fabrication, and implementation.
- Participation in initiatives to support continuous process improvement and real-time process metrics.
- Maintain and enforce Good Documentation Practices (GDP).
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
YOU’RE AWESOME AT:
- Strong knowledge of and demonstrated experience with equipment qualifications (DOE, IQ/OQ/PQ), process validations, mold qualifications, TMV, and GR&R methodologies and requirements.
- Understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
- Knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
- Knowledge of statistical techniques such as hypothesis testing (ANOVA) and confidence intervals.
- Ability to forge strong, effective, and transparent relationships with vendors while also protecting Tandem’s interests.
- Experience with clearly conveying knowledge to all levels within, and outside of, the organization.
- Excellent skills in the following areas: verbal and written communication, interpersonal relationships, organization, and time-management.
- Ability to multi-task and problem-solve in a fast-paced, dynamic environment.
- Reliable, flexible, and detail orientated with a high sense of urgency.
- Ability to work independently.
- Ability to effectively use Microsoft Office suite, SolidWorks, Minitab, and other applicable software.
- Ability to dive into details, translate and statistically analyze data, and effectively report results through written and/or graphical formats.
- Ability to thoroughly investigate and troubleshoot problems, identify root cause(s), document findings, and implement appropriate corrective actions.
- Ability to facilitate large and small group meetings effectively.
- Capable of managing multiple priorities effectively and ability to research and recommend best course of action from several alternatives.
- Ability to travel internationally and domestically is required.
- 3 yrs. experience working in the following is preferred:
- Medical device Manufacturing, or an ISO 13485 & FDA-regulated industry
- Bachelor’s degree in Engineering, Biotechnology, or a related field of study; or equivalent combination of education and applicable job experience.
WHAT’S IN IT FOR YOU?
In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce; we reward, develop, and retain them too. Just one of the many reasons of how we #StayAwesome! To learn more about our culture and benefits please visit https://www.tandemdiabetes.com/careers.
BE YOU, WITH US!
Tandem is firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $86,000 - $104,000 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, equity, and a robust benefits package.
Tandem offers health care benefits such as medical, dental, vision, health savings accounts and flexible saving accounts. You’ll also receive 10 paid holidays per year, a minimum of 20 days of paid time off (starting in year 1) and have access to a 401k plan with company match. Learn more about Tandem’s benefits here!
YOU SHOULD KNOW:
Potential new employees must successfully complete a drug screen (excludes marijuana) and background check which includes criminal search, education certification and employment verification prior to hire.
We love a good referral! If you know someone that would be a great fit for this position, please share!
If you are applying for this job and live in California, please read Tandem’s CCPA Notice: https://www.tandemdiabetes.com/careers/california-consumer-privacy-act-notice-for-job-applicants.
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.