Sr. Product Development Engineer

A DAY IN THE LIFE

As a member of the product development team, the Sr. Product Development Engineer will be a key contributor to the design and development of the Company's insulin delivery disposables. This role will be instrumental in advancing the technical development of plastic components, particularly through injection molding and extrusion processes. The engineer will have hands-on experience in polymer processing, design for manufacturability, and cross-functional collaboration to support the development of safe, effective, and user-friendly medical devices.

The Sr PDE at Tandem is also responsible for:

• Participates as an integral member of a team developing and implementing cannula components for insulin infusion sets, including soft cannula designs, insertion mechanisms, and interfaces with infusion set tubing.
• Drives the development and optimization of plastic molded and extruded parts, ensuring high precision and biocompatibility for subcutaneous delivery.
• Partners with suppliers and contract manufacturers to develop and qualify molds, extrusion dies, and cannula forming processes.
• Manages development and testing at external test facilities/vendors.
• Collaborates with cross-functional teams including mechanical design, manufacturing, quality, and regulatory to ensure robust and compliant product development.
• Conducts feasibility studies, material selection, and tolerance analysis for cannula and related components.
• Supports design verification and validation activities, including mechanical, dimensional, and functional testing of cannula assemblies.
• Plans, designs, develops, and/or modifies test fixtures and equipment.
• Selects components and equipment based on analysis of requirements as well as component specifications and reliability.
• Utilizes root cause investigation methodologies to de-bug and solve design performance challenges.
• Designs and runs experiments, analyzes and summarizes data, and reports the results and conclusions.
• Authors and maintains technical documentation including design specifications, test protocols, and risk analyses in compliance with FDA and ISO standards.
• Participates in design reviews, FMEA sessions, and continuous improvement initiatives.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.

• Bachelor's degree in mechanical engineering, Biomedical Engineering or related field, or equivalent combination of education and applicable job experience.
• 4+ years of product development experience in the medical device field.
• Proven experience in/with the following:
  • Start-up environment, demonstrating adaptability, innovation, and the ability to thrive in a fast-paced setting.
  • Plastic injection molding and extrusion, particularly for small, high-precision components.
  • Driving process development and scale-up with both internal and external manufacturing partners.
  • Insulin infusion sets or other drug delivery systems involving cannulas or catheters.
  • DOE, statistical analysis tools (e.g., Minitab), and root cause analysis.
  • External manufacturing partners and suppliers.
• Strong track record of taking initiative and driving projects from concept to completion in a dynamic, entrepreneurial atmosphere.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Excellent communication, problem-solving, and project management skills.
• Able to communicate technical knowledge to varying levels within organization.
• Able to work effectively in a team environment at all levels within the organization.
• Able to alter behavior and opinions considering experimental data and business need.
• Strong medical device design and product development skills.
• Strong understanding of cannula design, subcutaneous delivery, and related biocompatibility considerations.
• Proficiency in CAD software (e.g., Solid Works) and tolerance stack-up analysis.
• Familiarity with design controls and regulatory requirements (FDA 21 CFR Part 820, ISO 13485).
• Knowledge of polymer materials used in medical applications (e.g., TPU, TPE, PEBA).
• Knowledge of Good Documentation Practices (GDP).

This is a hybrid position based in Irvine, CA with approximately 60% of non-travelling time spent in office. This position may require up to 75% travel to vendor sites depending where projects are in the development cycle and will require frequent travel to Tandem's San Diego area facilities (Headquarters and Barnes Canyon).

The starting base pay range for this position is $108,600 - $130,000 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 and a robust benefits package.

Tandem offers health care…