Product Development Engineer II (2x openings)
Product Development Engineer II (2x openings)
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Job Description
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. Wed 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 were so much more than that. Our companys 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 & WHERE YOULL WORK:
On-Site: This role is on-site five days a week at our Del Mar CA office due to the nature of the work involved.
A DAY IN THE LIFE:
Responsible for technical contributions to the development documentation testing analysis troubleshooting and debugging of the Companys products test and assembly fixtures and data collection systems.
The Product Development Engineer II position at Tandem is also responsible for:
- Participates in the research and development of components and systems for the Companys products utilizing knowledge of engineering theory and materials or component properties.
- Conducts mechanical design of the products and fixtures using SolidWorks.
- Builds and assesses mechanical designs using rapid prototyping technologies.
- Supports design and implementation of changes to existing products.
- Manages execution and documentation of design verification and validation testing.
- Writes detailed and easily understood work instructions test protocols and test reports.
- Utilizes root cause investigation methodologies to de-bug and solve design non-conformances.
- Performs tolerance analysis of parts and assemblies.
- Utilizes statistical analysis to understand and define process capabilities.
- Plans designs develops modifies and evaluates fixtures equipment and assembly processes.
- Drives the design development and qualification of medical device pilot assembly line.
- Designs and runs experiments analyzes and summarizes data and reports the results and conclusions.
- Participates in reviews of requirements data and process validation protocols/reports. Creates and reviews engineering drawings as needed using SolidWorks.
- Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
- Creates documentation required for qualification and operation of pilot assembly line.
- Participates in evaluating the reliability of materials components and systems.
- Performs and interprets troubleshooting of assembly process issues.
- Develops and manages development and testing at external test facilities/vendors.
- Reviews and assesses vendor capability to support development.
- Completes 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.
WHAT YOULL NEED:
- 2 years of product development experience in the medical device field.
- Bachelors degree in mechanical engineering biomedical engineering or related field or equivalent combination of education and applicable job experience.
- Strong understanding of mechanical engineering principles including materials fasteners fits/tolerances heat transfer and stress/strain.
- Skilled in SolidWorks for creating and modifying parts assemblies and detailed drawings.
- Strong understanding of how to apply the scientific method (hypothesis development experiment design and data interpretation) in an engineering context; root cause analysis is a primary example.
- Capable of applying statistical tools to summarize data identify trends and support engineering conclusions.
- Exposure to design verification activities including defining product requirements developing test methods conducting tests and writing reports.
- Experience with programming in Python or C and using tools like Raspberry Pis and Arduinos is preferred.
- Proficient in communicating technical concepts to different audiences with varying levels of technical knowledge and needs.
- Familiar with design controls and regulatory standards such as QSR ISO 14971 and IEC 60601.
- Knowledgeable in Good Documentation Practices (GDP).
EXTRA AWESOME:
- Experience in product development; experience with medical device design and manufacturing process development is preferred.
- Experience with dimensional tolerance analysis; knowledge of Geometric Dimensioning & Tolerancing (GD&T) and statistical tolerancing is preferred.
- Familiarity with basic electronic components such as capacitors inductors resistors PCBs and connectors is preferred.
WHY YOULL LOVE WORKING HERE:
At Tandem we believe joy fuels excellence. Thats why weve 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 YOU WITH US!
We embrace the value that every single one of us brings to the table. But sometimes we forget that when we dont meet 100% of a job descriptions criteria maybe youre 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.
COMPENSATION & BENEFITS:
The starting base pay range for this position is $90K - $100K annually. Base pay will vary based on job-related knowledge skills experience and may also fluctuate depending on candidates 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.
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.
Tandem has good cause to conduct a review of criminal history for this position as this position will have access to customers protected health information and regular contact with customers. 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.
REFERRALS:
We love a good referral! If you know someone who would be a great fit for this position please share!
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.
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 were turning challenges into triumphs every day and where your talents will help shape a healthier happier tomorrow.
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Employment Type
Full-Time
